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Peptide — Dual GLP-1/GIP Receptor Agonist

CT-388

Limited Human Data

Enicepatide (INN) · RO7795068 · RG6640 · a lipidated peptide of 38 building blocks · Carmot Therapeutics, now Roche

A lab-made peptide built to switch on the receptors for two gut hormones, GLP-1 and GIP, as tirzepatide does. Made by Carmot Therapeutics and now Roche’s, it is in Phase 3 trials as a once-weekly weight-loss injection; Roche calls it investigational, and no health authority has approved it (Chakravarthy et al., 2026; NCT07351045; Roche, September 22, 2026).

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Molecular Weight
4,825.4 g/mol (C226H345FN48O67)
Sequence
38 residues: βA*-EGTFTSDYSI-Aib-LDKIAQK†AFVQWLIAGGPSSGAPPPS-NH₂ (*capped, †fatty acid)
Half-life
123–151 hours in people (about 5–6 days), after SubQ doses
Route (studied)
SubQ (people) · SubQ (mice, monkeys)
Route (sold)
Trials only; lab-reagent powder (research use only)
FDA Status
Not approved · not on FDA’s 503A or 503B lists
Pipeline
Phase 3 ENITH-1 (obesity or overweight without type 2 diabetes) (NCT07351045), primary completion est. Jul 2028; Phase 3 ENITH-2 (obesity or overweight with type 2 diabetes) (NCT07351058), primary completion est. Aug 2028; Phase 3 in Chinese adults with obesity or overweight, with or without type 2 diabetes (NCT07670416), primary completion est. Feb 2028; +2 more →
Developer
Carmot Therapeutics; Roche since its December 2023 deal
Development
Phase 3 (ENITH-1, ENITH-2) since March 2026
Published Studies
3 PubMed records for “CT-388” (Oct 4, 2026); 1 is about CT-388 itself
Human Studies
1 published Phase 1 RCT (64 people) · 2 Phase 2 RCTs, results not yet in a journal
WADA Status
Not named — prohibited at all times under S0 (no government has approved it for human use)
Evidence Strength
Published: Phase 1, 48 people on CT-388, up to 4 weeks
Phase 2 (469 and 447 adults): Roche releases, slides and one abstract
Cost & Access
Trials only; lab-reagent powder labelled not for human use

Gray market · not on any FDA 503A list · Tell me if this changes →

The other four questions

What does it do? In cell tests it switches on the GLP-1 and GIP receptors while recruiting little β-arrestin, so the receptors stay on the cell surface (Chakravarthy et al., 2026). In the one published trial, four weekly injections cut weight by 4.1–7.5% more than placebo by day 29 in adults with overweight or obesity (Chakravarthy et al., 2026); Roche reports 22.5% more weight loss than placebo at 48 weeks on the top dose of its Phase 2 if everyone had stayed on treatment, or 18.3% counting everyone randomized (Roche, January 27, 2026).
Who uses it? Trial volunteers: 129 enrolled in the Phase 1, 469 and 447 in the two Phase 2 trials, and about 3,900 planned for three Phase 3 trials (NCT04838405; NCT06525935; NCT06628362; NCT07351045; NCT07351058; NCT07670416). Outside the trials, chemical suppliers list it as a lab reagent labelled not for human use (PubChem, 2026); no document read for this page shows anyone taking it outside a trial.
Does the evidence hold up? Partly. The only peer-reviewed human study is a Phase 1 in 64 adults, 48 of them on CT-388 (30 for one dose, 18 for four weekly doses), whose sponsor helped design, analyze and write it (Chakravarthy et al., 2026). The 48-week results come from a conference abstract and Roche’s releases and slides (Lingvay et al., 2026; Roche, January 27, 2026; Roche, June 8, 2026; Roche, September 22, 2026; Roche, September 28, 2026), and no outside group has published a study of it (PubMed, searched October 4, 2026).
Bottom line? A once-weekly weight-loss injection in Phase 3 trials that run to 2028 (NCT07351045; NCT07351058), with one small published trial and larger Phase 2 results that so far exist only in a conference abstract and Roche’s releases and slides. No health authority has approved it, and what is sold outside the trials is lab-reagent powder labelled not for people (see Legal Status).

Dosing from the Literature

Published for fat loss: single doses of 0.5 to 7.5 mg, and four weekly doses stepped up from 5 mg to 7.5 or 12 mg, in adults with overweight or obesity (Chakravarthy et al., 2026). Not published: a full paper on the Phase 1’s two 22 mg cohorts (24 weeks, and 12 weeks in type 2 diabetes) or on the 48-week Phase 2 trials (up to 24 mg), which appear only in conference abstracts and Roche’s documents; no dose is approved.

No dose of CT-388 is approved. The table records the doses given in Carmot’s and Roche’s trials, as the paper, the conference abstracts, the trial records and Roche’s documents give them. All were injections under the skin (Chakravarthy et al., 2026; NCT06525935; NCT06628362). They are trial doses, not recommendations.

SourceAmountFrequencyDurationPopulationNotes
Trial dose, Phase 1 single doses (Chakravarthy et al., 2026; NCT04838405)0.5, 2, 5, 6 or 7.5 mg SubQOne doseSingle dose; weight reported at day 840 adults aged 18–65 with a BMI of 25 or more and no diabetes, in Australia (30 on CT-388)Weight change against placebo at day 8: +0.8% at 0.5 mg to −3.1% at 7.5 mg. At 7.5 mg, 5 of 6 had nausea.
Trial dose, Phase 1 weekly doses (Chakravarthy et al., 2026; NCT04838405)5, 5, 5, 7.5 mg · 5, 5, 8, 12 mg · 5, 8, 12, 12 mg SubQ (three cohorts)Once a week, four doses4 weeks; weight measured at day 2924 adults aged 18–65 with overweight or obesity and no diabetes, in Mexico (18 on CT-388)Weight 4.1%, 5.6% and 7.5% lower than on placebo at day 29. No serious adverse events.
Phase 1b cohort, conference abstract (Steinberg et al., 2025, abstract 125-OR; Roche, May 16, 2024)Stepped up to 22 mg SubQOnce a week24 weeks31 adults with obesity and no diabetes, randomized 4:1 to CT-388 or placeboWeight 18.8% lower than on placebo (Roche); 18.9% in the abstract. Not in a journal.
Phase 1 cohort with diabetes, conference abstract (Steinberg et al., 2025, abstract 763-P)22 mg SubQOnce a week12 weeks19 adults with obesity and type 2 diabetes on diet and exercise or metformin, HbA1c 7.0–10.0%, randomized 4:1HbA1c −3.0% against −0.2% on placebo; weight −8.6% against −1.2%. Not in a journal.
Trial dose, Phase 2 CT388-103 (Lingvay et al., 2026; Roche, June 8, 2026; NCT06525935)4, 8, 12, 16 or 24 mg SubQ, by group; 80% of the 24 mg group reached 24 mgOnce a week at the study site, stepped up within the first 27 weeks to the highest dose tolerated48 weeks467 adults aged 18–75 with a BMI of 30 or more, or 27 or more with a weight-related condition; no diabetesMean weight change at week 48, if all had stayed on treatment: −6.7% at 4 mg to −22.7% at 24 mg, against −0.2% on placebo; counting everyone randomized, 18.3% more than placebo at 24 mg. Abstract and Roche documents; no paper yet.
Trial dose, Phase 2 CT-388-104 (Roche, September 22, 2026; NCT06628362)Four dose levels, up to 24 mg SubQ; the registry does not give the levelsOnce a week48 weeks447 adults with type 2 diabetes (HbA1c 7–10.5%) and a BMI of 25 or more, on diet and exercise, metformin or an SGLT-2 inhibitorAt 24 mg, if all had stayed on treatment, HbA1c −2.65% from 8.1% (−0.43% on placebo); weight −15.5% (Roche, September 22, 2026; Roche, September 28, 2026). No results posted or published.
Phase 3 trial records (NCT07351045; NCT07351058; NCT07670416)Three dosing regimens; doses not disclosedOnce a week72 weeks (52 in the trial in China)About 3,900 adults with obesity or overweight, with or without type 2 diabetesRecruiting. In ENITH-1 and ENITH-2, participants inject it themselves with an integrated drug-device product (NCT07351045; NCT07351058).
Dosing Disclaimer

CT-388 is investigational, and no dose is approved (Drugs@FDA and the EMA medicines list, searched October 4, 2026). These rows are doses given in the developer’s trials; the Phase 1’s 22 mg doses and the Phase 2 doses come from conference abstracts and company documents, not a peer-reviewed paper (Steinberg et al., 2025, abstract 125-OR; Steinberg et al., 2025, abstract 763-P; Lingvay et al., 2026; Roche, June 8, 2026). No study has tested any product sold outside the trials. None of this is a dosing guide. Always work with a licensed healthcare provider.

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What It Is

CT-388 is a synthetic peptide that switches on the receptors for two gut hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) (Chakravarthy et al., 2026). In 2025 WHO published enicepatide as its proposed international nonproprietary name, with the formula C226H345FN48O67, and classed it as a dual GIP and GLP-1 receptor agonist and an antidiabetic (WHO, 2025); FDA’s substance registry also lists enicepatide as its US adopted name (FDA GSRS). Roche also codes it RO7795068 and RG6640 (NCT06525935), and the developers give its molecular weight as 4,825.4 g/mol (Chakravarthy et al., 2026).

FDA’s substance registry lists its chain as 38 building blocks: X-EGTFTSDYSI-X-LDKIAQKAFVQWLIAGGPSSGAPPPS, where the first X is a β-alanine capped with a small fluorine-carrying chemical group, the second X is 2-methylalanine (Aib), the lysine at position 19 carries a 20-carbon fatty diacid on a linker, and the end is amidated (FDA GSRS; WHO, 2025). Set against tirzepatide’s record, positions 2 to 38 match tirzepatide’s positions 3 to 39, including tirzepatide’s second Aib, the same fatty-acid side chain on the same lysine and the amidated end; the difference is at the start, where tirzepatide’s first two building blocks, tyrosine and Aib, are replaced by the capped β-alanine (FDA GSRS; Zepbound label).

Carmot Therapeutics, a private company in Berkeley, California, found CT-388 by screening thousands of variants of a dual GLP-1/GIP peptide with its Chemotype Evolution platform, choosing for cAMP signaling with little β-arrestin recruitment at both receptors (Chakravarthy et al., 2026; Roche, December 4, 2023). Its first human trial began in April 2021 (NCT04838405). In December 2023 Roche agreed to buy Carmot for USD 2.7 billion upfront plus up to USD 400 million in milestone payments, naming CT-388 the lead asset (Roche, December 4, 2023). Roche has since reported a 24-week Phase 1b cohort (Roche, May 16, 2024) and two 48-week Phase 2 trials (Roche, January 27, 2026; Roche, September 22, 2026), and two Phase 3 trials, ENITH-1 and ENITH-2, began in March 2026 (NCT07351045; NCT07351058).

In March 2025 Roche and Zealand Pharma agreed to develop Zealand’s amylin analog petrelintide alone and as a fixed-dose combination with CT-388 (Roche, March 12, 2025). CT-388 is not CT-996, a once-daily oral small-molecule GLP-1 receptor agonist from the same Carmot deal, nor CT-868, a once-daily injectable GLP-1/GIP agonist meant for people with type 1 diabetes and overweight or obesity (Roche, December 4, 2023); Roche listed CT-868, now named acmopatide, as not advancing to Phase 3 in June 2026 (Roche, June 8, 2026).

PubMed returns 3 records for “CT-388” and none for “enicepatide” (October 4, 2026): the developers’ paper on CT-388 itself (Chakravarthy et al., 2026) and two reviews that mention it (Jepsen & Christensen, 2021; Neumann et al., 2026). No health authority has approved it (see Legal Status).

Mechanism of Action

The findings below come from cell tests, mice and monkeys in the developer’s paper, and from what its first human trial measured (Chakravarthy et al., 2026). The design’s proposed advantage, biased signaling, has not been tested against an unbiased drug in people (PubMed and ClinicalTrials.gov, searched October 4, 2026).

  • GLP-1 and GIP receptors (cAMP signaling) — In cell lines carrying the human receptors, CT-388 fully activated the GLP-1 receptor (half-maximal concentration 0.087 nM, 99% of the maximal response) and activated the GIP receptor to 92% of its maximal response (half-maximal concentration 2.47 nM). Compared with the natural hormones it was 4-fold less potent at the GLP-1 receptor and 42-fold less potent at the GIP receptor, so its potency leans toward GLP-1, and it produced no cAMP at the glucagon or GLP-2 receptors (Chakravarthy et al., 2026). Tirzepatide leans the other way: a Lilly-led analysis found that at clinically effective doses it engages the GIP receptor more than the GLP-1 receptor (Willard et al., 2020).
  • β-arrestin and receptor internalization (the “biased” design) — Unlike native GLP-1, CT-388 recruited almost no β-arrestin-2 to the human GLP-1 receptor (4% of the maximal response) and little to the GIP receptor (28%), and it barely pulled either receptor into the cell (6% at the GLP-1 receptor; below detection at the GIP receptor) (Chakravarthy et al., 2026). The developers hypothesize that receptors left on the cell surface keep signaling longer, giving longer-lasting effects on glucose and weight (Chakravarthy et al., 2026). In cells and mice, an Imperial College London group found that GLP-1 receptor agonists that recruit less β-arrestin and leave the receptor at the cell surface gave greater long-term insulin release and better blood glucose (Jones et al., 2018), and that in mice very large cuts in β-arrestin recruitment were needed for the full effect on blood glucose (Hinds et al., 2024). Tirzepatide is itself biased toward cAMP at the GLP-1 receptor but not at the GIP receptor (Willard et al., 2020).
  • Insulin release that depends on glucose — In a human beta-cell line, CT-388 raised glucose-stimulated insulin secretion (half-maximal concentration 6.4 nM), and in lean monkeys a single dose raised insulin and C-peptide and lowered blood glucose during an intravenous glucose test (Chakravarthy et al., 2026). In the Phase 1’s four-week weekly-dose part, glucose during an oral glucose test fell while insulin and C-peptide generally fell too, which the authors read as better insulin sensitivity (Chakravarthy et al., 2026).
  • Appetite — CT-388 cut food intake in lean and obese mice (Chakravarthy et al., 2026). Food intake was not measured in people; in the Phase 1’s four-week weekly-dose part, satiety scores rose and appetite scores fell on CT-388, and all 18 participants on weekly CT-388 reported decreased appetite as an adverse event, against none on placebo (Chakravarthy et al., 2026).
  • Long action (fatty-acid side chain) — CT-388 carries a 20-carbon fatty diacid on a lysine (WHO, 2025); tirzepatide’s label says its C20 fatty diacid enables albumin binding and prolongs its half-life (Zepbound label). In the Phase 1’s adults with overweight or obesity, CT-388’s half-life averaged 123–151 hours, and blood levels peaked about 24 hours after injections of 5 mg or more (Chakravarthy et al., 2026).

What the Research Shows

Every result below comes from animal work run by or for the developer, published in the same paper as the first human trial (Chakravarthy et al., 2026). In that paper CT-388 was injected under the skin: once in the lean mice and the monkeys, every day in the 21-day and 8-week mouse studies, and once a week in the people given repeated doses (Chakravarthy et al., 2026). The human studies are in the next section.

  • Lean mice, one dose — 6 nmol/kg cut body weight by about 10% against vehicle within 24 hours, with weight drifting back toward baseline by 96 hours, and reduced food intake (8 mice per group). Doses of 2–6 nmol/kg caused minimal conditioned taste aversion, while semaglutide at a dose matched for weight loss (20 nmol/kg) caused strong aversion (5–7 mice per group) (Chakravarthy et al., 2026).
  • Diet-induced obese mice, 21 days — 6 nmol/kg a day lowered body weight by about 25% against vehicle (7 mice per group) and lowered liver weight (5 per group) (Chakravarthy et al., 2026).
  • Genetically obese mice (MC4R knockout), 21 days — On 30 nmol/kg a day, weight fell about 20% from baseline while vehicle-treated mice gained about 8%, and food intake fell by about 41 g (43.5%) against vehicle; fasting glucose and insulin, fat-pad weight and liver weight were lower (5–6 mice per group) (Chakravarthy et al., 2026).
  • Fatty-liver model mice, 8 weeks — In mice on a diet that produces liver changes like those of human steatohepatitis (MASH), 6 nmol/kg a day lowered body weight by about 20%, against 1% on vehicle, lowered the liver enzymes ALT and AST, and reduced liver fat, ballooned liver cells and the fatty-liver activity score (8–9 mice per group) (Chakravarthy et al., 2026).
  • Monkeys, one dose — In lean cynomolgus monkeys, single doses of 0.15 or 0.5 mg/kg under the skin raised insulin and C-peptide and lowered blood glucose during an intravenous glucose test (4 monkeys per group) (Chakravarthy et al., 2026).
Research Limitations — One Developer, Mostly Mice

Every cell and animal study of CT-388 was run by or for its developer, Carmot, now part of Roche, and published in one paper whose sponsor took part in the design, analysis and writing (Chakravarthy et al., 2026). No outside laboratory has published a study of CT-388 (PubMed, searched October 4, 2026). In the longer mouse studies the mice were dosed daily, while the people on repeated doses were dosed weekly (Chakravarthy et al., 2026). The idea that biased signaling adds benefit rests on cell and mouse studies, among them the developer’s work on a different molecule, CT-859 (Rodriguez et al., 2025); the CT-388 paper itself notes that ecnoglutide, another cAMP-biased agonist, gave a modest weight effect in a 24-week trial in type 2 diabetes (Chakravarthy et al., 2026).

Human Data

Published in a peer-reviewed journal: one Phase 1 trial (Chakravarthy et al., 2026). Everything else comes from conference abstracts, Roche’s releases and slides, or trial registrations without posted results (ClinicalTrials.gov, searched October 4, 2026). Carmot or Roche sponsored every registered trial (ClinicalTrials.gov).

  • Phase 1, single and weekly doses, 64 adults (Chakravarthy et al., 2026) — Randomized 3:1, double-blind and placebo-controlled (NCT04838405), in adults aged 18–65 with overweight or obesity and no diabetes. The single-dose part enrolled 40 adults at one site in Australia, 30 of whom got one dose of 0.5–7.5 mg; the weekly part enrolled 24 adults at one site in Mexico, 18 of whom got four weekly doses stepped up from 5 mg to 7.5 or 12 mg. After the four weekly doses, weight at day 29 was 4.1%, 5.6% and 7.5% lower than on placebo in the three cohorts, 7.4 kg in the highest, and the loss held for up to two weeks after the last dose. Fasting glucose fell 5.2–7.8 mg/dL against 0.2 mg/dL on placebo. The half-life, 123–151 hours, fits weekly dosing. A 2023 conference abstract on the same cohorts gave larger differences from placebo, 4.8%, 6.4% and 8.5% (Chakravarthy et al., 2023); the figures above are the paper’s. The authors list as limits single sites, small numbers, four weeks of treatment and no comparator drug. The registry lists 129 enrolled across all parts of the trial; the paper reports 64 of them (NCT04838405).
  • Phase 1b, 24 weeks, 31 adults with obesity (Roche, May 16, 2024) — Another part of the same trial (NCT04838405) randomized 31 adults with obesity and no diabetes 4:1 to CT-388 stepped up to 22 mg once a week, or placebo (Steinberg et al., 2025, abstract 125-OR). Roche reported weight 18.8% lower than on placebo at week 24 (p < 0.001), with every participant on CT-388 losing more than 5% and 45% losing more than 20%, and said all those with prediabetes at the start had normal glucose by week 24 (Roche, May 16, 2024). A 2025 abstract gives the difference as 18.9% (95% CI 14–24%) and reports that, in the 27 with complete liver scans, liver fat fell 59% more than on placebo (Steinberg et al., 2025, abstract 125-OR). These results are not in a journal.
  • Phase 1, 12 weeks, 19 adults with obesity and type 2 diabetes — A further cohort of the same trial (NCT04838405), randomized 4:1 to 22 mg once a week or placebo, on diet and exercise or metformin, with HbA1c of 7.0–10.0% at entry. HbA1c fell 3.0% against 0.2% on placebo and weight 8.6% against 1.2%; all 14 on CT-388 reached an HbA1c of 6.5% or less, and there were no serious adverse events or stops for adverse events (Steinberg et al., 2025, abstract 763-P). Conference abstract only.
  • Phase 2 CT388-103, 48 weeks, adults without diabetes (NCT06525935) — Randomized, double-blind and placebo-controlled at 34 US sites, in adults aged 18–75 with a BMI of 30 or more, or 27 or more with a weight-related condition such as prediabetes or high blood pressure; the registry lists 469 enrolled. The 467 randomized were split equally between placebo and doses of 4, 8, 12, 16 or 24 mg, injected weekly at the study site; their mean age was 49, mean BMI 38, 68% were women and half had prediabetes (Lingvay et al., 2026; Roche, June 8, 2026). Doses were stepped up within the first 27 weeks to the highest dose each person tolerated, up to their group’s dose, and 4 mg was the least a person could take and stay in the study; 80% of the 24 mg group reached 24 mg (Roche, June 8, 2026). Estimated as if everyone had stayed on treatment, mean weight change at week 48 ran from −6.7% on 4 mg to −22.7% on 24 mg, against −0.2% on placebo, with no plateau on 24 mg; on that dose the difference from placebo was 22.5% on that basis and 18.3% counting everyone randomized (Lingvay et al., 2026; Roche, January 27, 2026; Roche, June 8, 2026). Of the 24 mg group who reached week 48, 47.8% had lost at least 20% and 26.1% at least 30%, and among those with prediabetes, 27 of 37 (73%) had normal glucose at week 48, against 3 of 40 (7.5%) on placebo (Lingvay et al., 2026; Roche, June 8, 2026). Roche adds that 54% on 24 mg ended with a BMI under 30, against 13% on placebo (Roche, January 27, 2026). The trial was funded by Carmot; its results are in an abstract, a poster and Roche releases, not a paper (Roche, June 8, 2026).
  • Phase 2 CT-388-104, 48 weeks, 447 adults with type 2 diabetes (NCT06628362) — Randomized, double-blind and placebo-controlled, in adults with type 2 diabetes (HbA1c 7–10.5%) and a BMI of 25 or more, managed with diet and exercise, metformin or an SGLT-2 inhibitor (NCT06628362). Roche reported that both main goals were met: on 24 mg, estimated as if everyone had stayed on treatment, HbA1c fell 2.65% from a baseline of 8.1% (0.43% on placebo), and 4.13% in those who started above 8.5%; 90% reached an HbA1c of 6.5% or less and 62% under 5.7%; and weight fell 15.5% at 48 weeks (Roche, September 22, 2026; Roche, September 28, 2026). The registry lists week 36 for both main outcomes; Roche reports week 48 (NCT06628362; Roche, September 22, 2026). No results are posted or published.
  • Phase 3 and other registered trials — ENITH-1 (about 2,000 adults with obesity or overweight and no type 2 diabetes) and ENITH-2 (about 1,600 with type 2 diabetes) compare three dosing regimens with placebo on weight change at week 72; both began in March 2026 at about 200 sites each, and participants inject the drug themselves with an integrated drug-device product (NCT07351045; NCT07351058). A Phase 3 in about 300 Chinese adults, with weight change at week 52 as its main result, and a Phase 1 in 36 healthy Chinese adults began in July 2026 (NCT07670416; NCT07626515). ZYNERGY, a Phase 2 of CT-388 with petrelintide, was not yet recruiting (NCT07589686). Roche plans Phase 3 trials in type 2 diabetes, one of them against tirzepatide, and in cardiovascular disease and heart failure, to start in the first half of 2027 (Roche, September 28, 2026).

The evidence meter on the CT-388 card reads “Human pilots”: it counts published human data on CT-388 itself, for fat loss, and the only peer-reviewed human study is the Phase 1 in 64 adults, of single doses or four weekly doses (Chakravarthy et al., 2026). The 48-week Phase 2 trials have so far been reported only in a conference abstract, slides and company releases (Lingvay et al., 2026; Roche, January 27, 2026; Roche, June 8, 2026; Roche, September 22, 2026; Roche, September 28, 2026).

Pipeline

  • Phase 3 ENITH-1 (obesity or overweight without type 2 diabetes) (NCT07351045), primary completion est. Jul 2028
  • Phase 3 ENITH-2 (obesity or overweight with type 2 diabetes) (NCT07351058), primary completion est. Aug 2028
  • Phase 3 in Chinese adults with obesity or overweight, with or without type 2 diabetes (NCT07670416), primary completion est. Feb 2028
  • Phase 2 ZYNERGY, with petrelintide (NCT07589686), primary completion est. Nov 2027
  • Phase 1 in healthy Chinese adults (NCT07626515), primary completion est. May 2027

Reconstitution & Storage

No paper, trial record or company document read for this page describes CT-388 as a powder to reconstitute, or gives a vial strength, concentration, storage temperature or shelf life for the trial product, so there is no mixing table here. In the trials it was injected under the skin once a week (Chakravarthy et al., 2026; NCT06525935).

  • How the trials gave it — In the obesity Phase 2, participants came to the study site every week for their dose (Roche, June 8, 2026). In the ENITH-1 and ENITH-2 Phase 3 trials, participants inject it themselves with an “integrated drug-device combination product” (NCT07351045; NCT07351058).
  • Storage — No storage instructions for the trial product appear in the documents read for this page. A chemical supplier’s catalogue listing deposited in PubChem, labelled not for human use, gives −20 °C for up to a year for the powder (PubChem, 2026).
  • Products outside the trials — What is sold is lab-reagent powder labelled for research use only (see Legal Status). No study has tested such a product in people, and no independent analysis of one has been published.

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Side Effects & Risks

What This Page Cannot Tell You

How safe CT-388 is over years, or for anyone outside the trials. The one peer-reviewed trial gave CT-388 for at most four weeks (Chakravarthy et al., 2026); the 48-week safety figures come from Roche’s slides and releases, not a peer-reviewed paper (Roche, June 8, 2026; Roche, September 22, 2026). What is sold outside the trials is lab-reagent powder labelled not for human use, and no analysis of such a product has been published.

  • Nausea, vomiting and other stomach effects — In the 48-week obesity Phase 2, stomach and bowel problems were reported by 47–65% of participants across the CT-388 doses against 28% on placebo: nausea 33–46% against 19%, vomiting 8–25% against 0%, diarrhea 14–32% against 10% and constipation 22–26% against 8%, with participants grouped by the highest dose they reached (Roche, June 8, 2026). Roche says most were mild to moderate (Roche, January 27, 2026).
  • Single doses in Phase 1 — One participant on 7.5 mg had moderate intractable vomiting, a serious event judged probably related to the drug; at 7.5 mg, 5 of 6 had nausea, 3 vomited, 3 had reflux and one had a Mallory-Weiss tear, a tear in the lining where the esophagus meets the stomach. One participant on 6 mg left the study after vomiting, diarrhea and abdominal pain, and one had a severe retinal detachment 7 days after a 6 mg dose, judged unrelated (Chakravarthy et al., 2026).
  • Weekly doses in Phase 1 — No serious events and no one stopped for an adverse event. All 18 on CT-388 reported decreased appetite, and in the first weekly cohort all 6 had nausea and 5 vomited; nausea and vomiting were less common in the two later cohorts, which had higher body weights (Chakravarthy et al., 2026).
  • Stopping treatment — In the obesity Phase 2, 5.9% of participants on CT-388 and 1.3% on placebo stopped because of adverse events (Roche, January 27, 2026): by dose group, 1% at 4 mg, 3% at 8 mg, 14% at 12 mg, 5% at 16 mg and 7% at 24 mg, against 1% on placebo (Roche, June 8, 2026). In the type 2 diabetes Phase 2, 2.0% on CT-388 and none on placebo stopped treatment because of adverse events (Roche, September 22, 2026). More people left the obesity trial’s placebo group for any reason (34%) than any CT-388 group (14–31%) (Roche, June 8, 2026).
  • Serious adverse events — In the obesity Phase 2, 1–5% of participants across the CT-388 doses had a serious adverse event, against none on placebo, and no one died; Roche calls serious and grade 3 events low and not dose-dependent (Roche, June 8, 2026).
  • Heart rate and blood pressure — In the Phase 1’s four-week weekly-dose part, heart rate in the fastest step-up cohort rose by a mean 15.8 beats per minute at day 29, against a fall of 5.5 on placebo; the authors call the rise transient. Systolic blood pressure fell 9.3 and 5.7 mmHg in two cohorts, against 0.3 on placebo, and ECGs showed no drug-related QTc change (Chakravarthy et al., 2026).
  • Liver and other lab tests — One participant on a single 7.5 mg dose had ALT and AST above three times the upper limit of normal the day after dosing, back to baseline by day 8 without treatment; the paper reports no other clinically significant laboratory changes (Chakravarthy et al., 2026). In the weekly part, five people on CT-388 had mild laboratory adverse events (creatine phosphokinase up in two; ALT up, lactate dehydrogenase up and a longer clotting time in one each), none judged related to the drug (Chakravarthy et al., 2026).
  • Low blood sugar — Roche reports no level 2 hypoglycemia in the type 2 diabetes Phase 2 (Roche, September 28, 2026).
  • Warnings on the label of tirzepatide, the approved drug of the same class — Tirzepatide’s label carries a boxed warning that it causes thyroid C-cell tumors in rats, with unknown relevance to people, and lists severe stomach and bowel reactions, kidney injury from fluid loss, gallbladder disease, pancreatitis, serious allergic reactions, low blood sugar with insulin or insulin secretagogues, worsening diabetic eye disease and aspiration under anesthesia (Zepbound label). These are tirzepatide’s warnings; CT-388 has no label. The CT-388 obesity Phase 2 excluded people with a personal or family history of medullary thyroid cancer or a calcitonin of 20 ng/L or more (NCT06525935).
  • What has not been tested — No animal toxicology study, drug-interaction study or study in pregnancy has been published (PubMed, searched October 4, 2026). The obesity Phase 2 excluded women who were pregnant or breastfeeding, and women who could become pregnant and were not using highly effective contraception (NCT06525935). No results beyond 48 weeks have been reported.
  • WADA — CT-388 is not named on the 2026 Prohibited List. Section S0 prohibits at all times substances not addressed elsewhere on the List “with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued…)” (World Anti-Doping Agency, 2026). No approval of CT-388 turned up for this page.

Bloodwork & Monitoring

No monitoring guidance for CT-388 has been published outside the trials, and there is no label. The trials measured these:

  • Body weight and waist — Weight change was the main result of the obesity Phase 2 (NCT06525935); weight and hip and waist circumference were measured in Phase 1 (Chakravarthy et al., 2026).
  • Blood sugar — Fasting glucose, insulin, HOMA-IR, HbA1c and an oral glucose tolerance test in Phase 1 (Chakravarthy et al., 2026); HbA1c as a main result in the type 2 diabetes Phase 2 (NCT06628362).
  • Liver and kidney tests — ALT, AST, bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatinine and blood urea nitrogen in Phase 1 (Chakravarthy et al., 2026), and liver fat by MRI in the 24-week cohort (Steinberg et al., 2025, abstract 125-OR).
  • Heart — Vital signs and ECGs (Chakravarthy et al., 2026).
  • Calcitonin — A blood calcitonin of 20 ng/L or more kept people out of the obesity Phase 2 (NCT06525935).
  • Which tests fit a given person — A question for a licensed healthcare provider. This page can’t answer it.

Commonly Stacked With

No study has tested CT-388 together with another compound on this site (PubMed and Europe PMC, searched October 4, 2026); in its type 2 diabetes trials it was given on top of diet and exercise, metformin or an SGLT-2 inhibitor (NCT06628362; Steinberg et al., 2025, abstract 763-P). Roche and Zealand Pharma plan a fixed-dose combination of CT-388 with petrelintide, Zealand’s amylin analog (Roche, March 12, 2025); the Phase 2 ZYNERGY trial plans to test the two together and each alone in an estimated 486 adults, and was not yet recruiting on October 4, 2026, so no results exist (NCT07589686).

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Legal Status

Current Status — October 2026

Not FDA-approved; not on FDA’s 503A or 503B lists. Drugs@FDA holds no application for CT-388 or enicepatide, and FDA’s NDC directory and drug labels (openFDA) and DailyMed hold no product (searched October 4, 2026). It is not on the 503A bulks list (21 CFR 216.23), the list of drug products withdrawn or removed from the market for reasons of safety or effectiveness (21 CFR 216.24), FDA’s 503A categories list (updated May 14, 2026) or its 503B categories list (updated March 21, 2025). No FDA warning letter names it (FDA warning-letter search, October 4, 2026). FDA’s page on unapproved GLP-1 drugs, current as of October 1, 2026, warns about products falsely labelled “for research purposes” that contain semaglutide, tirzepatide, retatrutide, survodutide or mazdutide; it does not name CT-388 (FDA, October 1, 2026).

Elsewhere: no entry in the European Medicines Agency’s list of medicines (read October 4, 2026), and no approval by any health authority turned up for this page. Roche runs its Phase 3 trials in Europe, the Americas and Asia, China among them (NCT07351045; NCT07670416).

WADA does not name CT-388 on its 2026 Prohibited List; S0 applies (Prohibited List 2026; see Side Effects & Risks).

ClinicalTrials.gov lists 8 studies of CT-388 (searched October 4, 2026): two completed (the Phase 1 and the obesity Phase 2), one active and not recruiting (the type 2 diabetes Phase 2), four recruiting (ENITH-1, ENITH-2, the Phase 3 in China and a Phase 1 in China) and one not yet recruiting (ZYNERGY, with petrelintide).

Cost & Access

No CT-388 product is approved or sold as a medicine, and no price for it as a medicine has been published. In the documents read for this page it is given to people only in Carmot’s and Roche’s trials. Outside them, chemical suppliers list enicepatide as a research reagent, labelled for research use only and not for human use; one supplier’s catalogue listing deposited in PubChem offers it as a solid in 10, 100 and 500 mg amounts, with prices on request (PubChem, 2026; catalogue searches of October 4, 2026). No study has tested any of these products.

Pricing and availability vary and are set by the seller. Kalios does not sell compounds.

References

  1. Chakravarthy MV, Rodriguez R, Hergarden A, Elliott MA, et al. Effects of CT-388, a once-weekly signaling-biased dual GLP-1/GIP receptor agonist, on weight loss and glycemic control in preclinical models and participants with obesity. Mol Metab. 2026;103:102291. PMID: 41319798. DOI: 10.1016/j.molmet.2025.102291. (Full text at PMC12771327, read October 4, 2026. Funded by Carmot Therapeutics, now part of Roche, which took part in the design, analysis and drafting.)
  2. Chakravarthy M, Argüelles-Tello F, Sun A, Elliott M, et al. 75-LB: CT-388, a Novel Once-Weekly Dual GLP-1 and GIP Receptor Modulator, Is Safe, Well-Tolerated, and Produces More than 8% Weight Loss in Four Weeks in Overweight and Obese Adults. Diabetes. 2023;72(Supplement_1):75-LB. DOI: 10.2337/db23-75-lb. (Conference abstract.)
  3. Steinberg A, Argüelles-Tello F, Zhu J, Wu J, et al. 125-OR: Effect of CT-388, a Signal-Biased Dual GLP-1/GIP Receptor Agonist, on Liver-Related MRI Parameters in Patients with Obesity. Diabetes. 2025;74(Supplement_1):125-OR. DOI: 10.2337/db25-125-or. (Conference abstract; cited as Steinberg et al., 2025, abstract 125-OR.)
  4. Steinberg A, Argüelles-Tello F, Sánchez-Sánchez L, Ortiz W, et al. 763-P: Glycemic Control, Weight Reduction, and Safety with CT-388, a Signal-Biased Dual GLP-1/GIP Receptor Agonist—Results from a 12-Week Cohort in Adults with Obesity and Type 2 Diabetes. Diabetes. 2025;74(Supplement_1):763-P. DOI: 10.2337/db25-763-p. (Conference abstract; cited as Steinberg et al., 2025, abstract 763-P.)
  5. Lingvay I, Jastreboff A, Lender D, Bays H, et al. 2813-LB: CT-388, a cAMP Signal-Biased GLP-1/GIP Receptor Agonist, Achieves Clinically Meaningful Weight Loss in People With Overweight/Obesity: A 48-Week Phase 2 Study. Diabetes. 2026;75(Supplement_1):2813-LB. DOI: 10.2337/db26-2813-lb. (Late-breaking conference abstract, ADA 2026.)
  6. Rodriguez R, Hergarden A, Krishnan S, Morales M, et al. Biased agonism of GLP-1R and GIPR enhances glucose lowering and weight loss, with dual GLP-1R/GIPR biased agonism yielding greater efficacy. Cell Rep Med. 2025;6(6):102156. PMID: 40460831. DOI: 10.1016/j.xcrm.2025.102156. (Carmot’s mouse study of CT-859, a different molecule.)
  7. Willard FS, Douros JD, Gabe MB, Showalter AD, et al. Tirzepatide is an imbalanced and biased dual GIP and GLP-1 receptor agonist. JCI Insight. 2020;5(17):e140532. PMID: 32730231. DOI: 10.1172/jci.insight.140532.
  8. Jones B, Buenaventura T, Kanda N, Chabosseau P, et al. Targeting GLP-1 receptor trafficking to improve agonist efficacy. Nat Commun. 2018;9(1):1602. PMID: 29686402. DOI: 10.1038/s41467-018-03941-2.
  9. Hinds CE, Peace E, Chen S, Davies I, et al. Abolishing β-arrestin recruitment is necessary for the full metabolic benefits of G protein-biased glucagon-like peptide-1 receptor agonists. Diabetes Obes Metab. 2024;26(1):65-77. PMID: 37795639. DOI: 10.1111/dom.15288.
  10. Jepsen MM, Christensen MB. Emerging glucagon-like peptide 1 receptor agonists for the treatment of obesity. Expert Opin Emerg Drugs. 2021;26(3):231-243. PMID: 34176426. DOI: 10.1080/14728214.2021.1947240. (Review.)
  11. Neumann J, Kirchefer U, Hofmann B, Gergs U. Future GLP-1 receptor co-agonists and their cardiac effects. Naunyn Schmiedebergs Arch Pharmacol. 2026. PMID: 42768195. DOI: 10.1007/s00210-026-05908-3. (Review.)
  12. World Health Organization. Proposed International Nonproprietary Names: List 133. WHO Drug Information. 2025;39(2):515. Enicepatide: dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonist, antidiabetic; C226H345FN48O67; CAS 2869147-44-2. cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl133.pdf. Read October 4, 2026.
  13. FDA. Global Substance Registration System: Enicepatide, UNII MTP9QR7GYF (synthetic peptide, 38 residues, XEGTFTSDYSIXLDKIAQKAFVQWLIAGGPSSGAPPPS; residue 1 an N-capped β-alanine, residue 12 Aib, lysine 19 carrying a C20 diacid (icosanedioyl) on a γ-Glu and two-unit ethylene-glycol linker, serinamide end; names CT-388 and RO7795068; INN and USAN), and tirzepatide, UNII OYN3CCI6QE (39 residues, Aib at 2 and 13, the same lysine side chain at 20, serinamide end). gsrs.ncats.nih.gov. Read October 4, 2026.
  14. Eli Lilly and Company. Zepbound (tirzepatide) injection prescribing information. DailyMed set ID 487cd7e7-434c-4925-99fa-aa80b1cc776b (version effective August 28, 2026): boxed warning, warnings and precautions (5.1–5.9), description (11) and mechanism of action (12.1). dailymed.nlm.nih.gov. Read October 4, 2026.
  15. FDA. Drugs@FDA: tirzepatide, NDA 215866 (Mounjaro, first approved May 13, 2022) and NDA 217806 (Zepbound, first approved November 8, 2023), both Eli Lilly and Company, marketed by prescription. api.fda.gov/drug/drugsfda.json. Read October 5, 2026.
  16. Roche. Roche enters into a definitive merger agreement to acquire Carmot Therapeutics, including three clinical stage assets with best-in-class potential in obesity and diabetes. Media release, December 4, 2023. roche.com/media/releases/med-cor-2023-12-04. Read October 4, 2026.
  17. Roche. Roche reports positive Phase Ib results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity. Media release, May 16, 2024. roche.com/media/releases/med-cor-2024-05-16. Read October 4, 2026.
  18. Roche. Roche enters into an exclusive collaboration & licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity. Media release, March 12, 2025. roche.com/media/releases/med-cor-2025-03-12. Read October 4, 2026.
  19. Roche. Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity. Media release, January 27, 2026. roche.com/media/releases/med-cor-2026-01-27. Read October 4, 2026.
  20. Roche. Virtual ADA investor event, June 8, 2026: presentation, including the CT388-103 Phase 2 poster (Lingvay et al., 2813-LB) with its design, baseline, disposition, weight-change, normoglycemia and safety tables, and the CVRM pipeline slide. assets.roche.com/f/176343/x/20033a15c4/ada-ir-event_08-june-2026_final.pdf. Read October 4, 2026.
  21. Roche. Roche announces positive Phase II results for dual GLP-1/GIP receptor agonist enicepatide in people living with type 2 diabetes and overweight or obesity. Media release, September 22, 2026. roche.com/media/releases/med-cor-2026-09-22. Read October 4, 2026.
  22. Roche. Pharma Day 2026, September 28, 2026: presentation, Cardiovascular, Renal and Metabolism section (enicepatide Phase 2 results in obesity and type 2 diabetes; Phase 3 plans for 2027). assets.roche.com/f/176343/x/51deda2587/20260928_final_pharma-day-2026-publish-1.pdf. Read October 4, 2026.
  23. ClinicalTrials.gov. Registrations of CT-388 (enicepatide, RO7795068): NCT04838405 (Phase 1, Carmot, 129 enrolled, completed August 2024), NCT06525935 (Phase 2, CT388-103, 469 enrolled, completed December 2025), NCT06628362 (Phase 2, CT-388-104, 447 enrolled, active, not recruiting), NCT07351045 (Phase 3 ENITH-1, about 2,000, recruiting), NCT07351058 (Phase 3 ENITH-2, about 1,600, recruiting), NCT07670416 (Phase 3 in China, about 300, recruiting), NCT07626515 (Phase 1 in China, 36, recruiting) and NCT07589686 (Phase 2 ZYNERGY with petrelintide, 486 planned, not yet recruiting). None posts results. clinicaltrials.gov, API v2. Read October 4, 2026.
  24. FDA. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Content current as of October 1, 2026. fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss. Read October 4, 2026.
  25. PubChem. Substance records for enicepatide: SID 518139746 (FDA’s substance registration) and a chemical supplier’s catalogue listing (supplier not named), whose product page, read October 4, 2026, offers 10, 100 and 500 mg of solid, price on request, labelled “For research only, Do not use for Human!”, with storage of the powder at −20 °C for one year. pubchem.ncbi.nlm.nih.gov. Read October 4, 2026.
  26. FDA. Drugs@FDA, NDC directory and drug labels (openFDA, api.fda.gov), NLM DailyMed, and FDA’s warning-letter search: searches for “enicepatide” and “CT-388,” October 4, 2026 (no records). European Medicines Agency. Medicines data table (ema.europa.eu, medicines-output-medicines_json-report), read October 4, 2026 (no entry).
  27. Code of Federal Regulations. 21 CFR 216.23, bulk drug substances that can be used to compound drug products in accordance with section 503A, and 21 CFR 216.24, drug products withdrawn or removed from the market for reasons of safety or effectiveness. ecfr.gov. Read October 4, 2026.
  28. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated May 14, 2026. fda.gov/media/94155/download.
  29. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated March 21, 2025. fda.gov/media/94164/download.
  30. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S0, Non-approved substances. wada-ama.org.
  31. Searches of October 4, 2026: PubMed, “CT-388” (3 records: the developers’ paper and two reviews), “CT388” and “CT 388” (the same 3), “enicepatide,” “RO7795068” and “RG6640” (none); Europe PMC, “enicepatide” (1 record, a review-methods paper) and “CT-388” (45 hits; the only study of CT-388 itself is the developers’ paper); Crossref, CT-388 conference abstracts (four, in Diabetes, 2023–2026); ClinicalTrials.gov, “CT-388,” “CT388,” “RO7795068” and “enicepatide” (eight registrations, all sponsored by Carmot or Roche); PubMed, “CT-388” with petrelintide, semaglutide, tirzepatide or metformin (only the two reviews), with toxicology or toxicity (one review) and with interaction or pregnancy terms (none); Europe PMC, “CT-388” with petrelintide, semaglutide, tirzepatide or metformin, and with toxicology, pregnancy or drug-interaction terms (reviews only; no study of a combination, of toxicity, of interactions or in pregnancy); lab-reagent catalogues listing enicepatide for research use only (suppliers not named).

Checked 5 Oct 2026 |  Profile authored by Kalios Peptides research team

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