Enicepatide
Enicepatide is also called CT-388[1]. This synthetic peptide acts on GLP-1 and GIP receptors[2]. Studies test it for weight loss and blood sugar control[1]. A Roche-funded phase 2 trial found mean weight loss of up to 22.7% over 48 weeks[3]. Gut effects were the most common adverse events[3]. Larger phase 3 trials are recruiting[4]. Trial findings do not establish the contents of a separately bought vial.
What is Enicepatide?
The name describes one drug, not a mix of two peptides. In cell tests, CT-388 acted on both hormone receptors through cAMP signalling[2]. Few of the receptors moved inside the cells, compared with the response to the natural hormones. This is part of its signal-biased action. Cell findings do not establish a head-to-head clinical difference.
Human trials have now reported weight loss. Roche presented the phase 2 findings at the 2026 American Diabetes Association meeting[3]. The next stage tests people with and without type 2 diabetes. A trial phase names the research stage. It does not mean the drug is approved.
What has been published in humans?
What did the phase 2 obesity trial find?
Lingvay and colleagues reported a trial in adults without diabetes. The abstract says 467 people were assigned at random[3]. The trial record lists 469 enrolled[1]. These counts describe enrollment and random group assignment. They should not be swapped. The abstract names F. Hoffmann-La Roche as funder.
Roche's slides name Carmot Therapeutics, part of Roche, as the study funder[6]. Roche also paid for writing support. The table shows both change within a group and the gap versus placebo. The slides label the results with two different estimands.
| Week 48 measure | Finding | Source | Checked |
|---|---|---|---|
| Mean weight change, efficacy estimand | Placebo -0.2%; 4 mg -6.7%; 8 mg -14.2%; 12 mg -16.6%; 16 mg -18.4%; 24 mg -22.7% | NCT06525935; Roche slides, primary-endpoint figure[6] | 2026-09-06 |
| 24 mg versus placebo, efficacy estimand | -22.5 percentage points; 95% CI -25.3 to -19.8 | Same study and slides[6] | 2026-09-06 |
| Difference versus placebo, treatment estimand | 4 mg -5.0 (95% CI -8.4 to -1.6); 8 mg -10.7 (-14.0 to -7.4); 12 mg -11.7 (-15.0 to -8.4); 16 mg -13.4 (-16.7 to -10.0); 24 mg -18.3 (-21.6 to -14.9) percentage points | Same study and slides[6] | 2026-09-06 |
| Weight-loss thresholds, 24 mg | At least 5%: 95.7%; at least 10%: 87.0%; at least 20%: 47.8%; at least 30%: 26.1% | DOI 10.2337/db26-2813-LB[3] | 2026-09-06 |
| Normal glucose among those with prediabetes at entry | 73% with 24 mg versus 7.5% with placebo | Same abstract[3] | 2026-09-06 |
| BMI below 30 | 54% with 24 mg versus 13% with placebo | Roche's sponsor release[9] | 2026-09-06 |
The slides base the threshold rates on people who reached week 48, not all who joined the trial[6]. They report that 80% of the highest target-dose group reached that dose. People could change dose if it was hard to tolerate. These details matter when comparing trials.
Roche reports p < 0.001 for the 24 mg placebo-adjusted estimates under both estimands[9]. The company also reports that weight loss had not reached a plateau at week 48. That is a finding within the trial's follow-up, not a prediction of how long weight loss would continue.
What did the earlier studies find?
The phase 1 programme had several groups under one trial number, NCT04838405[10]. A paper and meeting reports describe different groups in that programme. Each report is not a new trial. The full paper says Carmot paid for the work and helped design, analyse and write it up[2].
| Report and people | Weight or glucose finding | Funding and limit | Checked |
|---|---|---|---|
| Full phase 1 paper: 40 single-dose participants; 24 in the four-week cohorts | Day 29 placebo-adjusted weight changes: cohort 6 -4.1% (95% CI -6.37 to -1.80); cohort 7 -5.6% (-7.93 to -3.28); cohort 8 -7.5% (-9.81 to -5.25)[2] | Carmot. Each four-week active cohort had six people; pooled placebo had six. Small, short, single-centre cohorts. | 2026-09-06 |
| EASD 2024: 12 people on the 8 mg target and three on placebo; 24 on the 22 mg target and seven on placebo | At week 12, mean weight changes were -10.2% at the 8 mg target and -12.4% at the 22 mg target, versus -0.9% placebo. At week 24, the 22 mg cohort had -18.9% versus -0.1% placebo[7]. | Carmot, part of Roche. Meeting report; not everyone finished at the target dose. | 2026-09-06 |
| ADA 2025: 19 adults with obesity and type 2 diabetes, including 14 given CT-388 and five placebo | At week 12, weight fell 8.6% versus 1.2%; adjusted difference 7.4% (95% CI 4.9 to 9.8). HbA1c fell 3.0 versus 0.2 percentage points; adjusted difference 2.8 (95% CI 2.1 to 3.6)[8]. | Carmot-sponsored programme. The abstract discloses Roche/Carmot employment but has no separate funding line. | 2026-09-06 |
In the group with diabetes, all 14 people given the drug reached HbA1c at or below 6.5%[8]. Seven reached below 5.7%. All 14 lost at least 5% of their weight. This was a small group reported at a meeting. Its rates do not apply to everyone who might use the drug.
What side effects and safety findings were recorded?
What did phase 2 report?
The phase 2 safety slides list gut effects alongside serious events[6]. They say most gut events were mild or moderate. No fatal event was reported. Roche reports no new or unexpected safety signal[9]. Carmot funded this study, and Roche funded writing support.
The table gives the reported percentages, except for the event-count row. The slide groups its analysis by the highest dose reached. It says group sizes may vary. It prints placebo 79, then 79, 78, 77, 78 and 76 for the five dose groups[6].
| Safety measure | Placebo | 4 mg | 8 mg | 12 mg | 16 mg | 24 mg |
|---|---|---|---|---|---|---|
| At least one adverse event | 64 | 76 | 81 | 79 | 82 | 86 |
| Total events (count) | 195 | 324 | 356 | 471 | 455 | 564 |
| At least one serious event | 0 | 4 | 3 | 3 | 1 | 5 |
| Fatal event | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrawn from study due to an event, safety slide | 1 | 1 | 0 | 1 | 0 | 0 |
| Gut disorder | 28 | 49 | 47 | 52 | 58 | 65 |
| Nausea | 19 | 33 | 36 | 39 | 41 | 46 |
| Constipation | 8 | 26 | 23 | 22 | 24 | 24 |
| Diarrhoea | 10 | 14 | 14 | 16 | 18 | 32 |
| Vomiting | 0 | 8 | 12 | 25 | 23 | 21 |
Source: NCT06525935, Roche safety slide; checked 2026-09-06[6].
The slides report no grade 4 or 5 events[6]. Their event-count row counts repeat events in the same person. The percentage rows count each person once for the same event.
The slide on who stayed in the trial gives a different AE-stop row: 1%, 1%, 3%, 14%, 5% and 7%, in the same group order[6]. Roche says events led 5.9% of people on the drug to stop it, versus 1.3% on placebo[9]. These rows are reported apart. The slides do not fully explain why their two event-stop rows differ.
What did phase 1 record?
The full phase 1 paper reports two serious events after single doses[2]. A retinal detachment after 6 mg was judged unrelated to the drug. Intractable vomiting after 7.5 mg was judged probably related. No death was reported.
| Cohort or finding | Recorded detail | Source and funding | Checked |
|---|---|---|---|
| Single-dose withdrawal | One person stopped after 6 mg with vomiting, diarrhoea and abdominal pain, judged possibly drug-related. | PMID 41319798; Carmot[2] | 2026-09-06 |
| Other single-dose findings | Severe nausea was judged probably related. The table also records Mallory-Weiss syndrome, reflux, altered bowel habit, constipation, abdominal distension and upper abdominal pain. Headache and contact dermatitis were among common events. | Same paper and funder[2] | 2026-09-06 |
| Liver tests after a single dose | One person at 7.5 mg had ALT/AST above three times the upper limit on day 1. Values returned to baseline by day 8 without intervention. | Same paper and funder[2] | 2026-09-06 |
| Four-week cohorts | No serious or severe event, event-related discontinuation or death. Gut events affected 83.3% of treated people. Reported events included nausea, vomiting, diarrhoea, constipation, bloating, dyspepsia, belching and reflux. | Same paper and funder[2] | 2026-09-06 |
| Four-week appetite and other checks | All 18 treated people reported reduced appetite; none on placebo did. No hypersensitivity, hyposensitivity or injection-site reaction was reported. No important ECG change or drug-related QTc signal was found. | PMID 41319798; Carmot[2] | 2026-09-06 |
| Four-week laboratory findings | Five mild lab events: raised creatine phosphokinase in two people, raised ALT in one, raised LDH in one and prolonged aPTT in one. None was judged drug-related. | Same paper and funder[2] | 2026-09-06 |
| Four-week heart rate | Cohort 8 had a mean rise of 15.8 beats/minute (SD 11.5) at day 29; placebo had a fall of 5.5 (SD 3.4). The authors describe the rise as transient. | Same paper and funder[2] | 2026-09-06 |
| Longer phase 1 cohorts | One serious spontaneous abortion in the 8 mg cohort was judged unrelated. Severe events in the 22 mg cohort were food poisoning in one person and brief creatine kinase rises in two, judged unrelated. A pregnancy led to discontinuation and a healthy newborn. | EASD LBA65; Carmot/Roche[7] | 2026-09-06 |
| Diabetes cohort | No serious event or event-related discontinuation. Gut events were most common, mostly mild and brief. No clinically notable lab or vital-sign change was reported. | DOI 10.2337/db25-763-P; Carmot-sponsored programme[8] | 2026-09-06 |
In the longer 22 mg cohort, gut-event rates fell for several symptoms during maintenance[7]. Nausea was reported in 83.3% during the first 12 weeks and 54.2% during weeks 12 to 24. Vomiting fell from 75.0% to 33.3%. These period rates concern the same cohort of 24 people, not separate samples.
The EASD report lists these gut-related events by period[7]. All were mild or moderate. Carmot funded the study, and Roche paid for writing support.
| Event (%) | Pooled placebo, weeks 0-12 (n=10) | 8 mg target, weeks 0-12 (n=12) | 22 mg target, weeks 0-12 (n=24) | Same 22 mg cohort, weeks 12-24 |
|---|---|---|---|---|
| Nausea | 20.0 | 41.7 | 83.3 | 54.2 |
| Vomiting | 10.0 | 25.0 | 75.0 | 33.3 |
| Diarrhoea | 20.0 | 50.0 | 54.2 | 50.0 |
| Constipation | 0 | 75.0 | 58.3 | 50.0 |
| Decreased appetite | 40.0 | 91.7 | 91.7 | 4.2 |
| Belching | 20.0 | 58.3 | 54.2 | 37.5 |
| Soft stools | 10.0 | 41.7 | 50.0 | 33.3 |
| Abdominal distension | 10.0 | 25.0 | 20.8 | 0 |
| Dyspepsia | 0 | 8.3 | 58.3 | 37.5 |
| Early satiety | 0 | 0 | 45.8 | 0 |
| Abdominal pain | 0 | 0 | 20.8 | 4.2 |
Source: EASD LBA65, NCT04838405; checked 2026-09-06[7].
What dosage information do sources report for Enicepatide?
The published amounts are study doses. The later trials allowed dose changes if people could not tolerate a dose[6]. A target dose was not always the dose each person reached. The table gives reported amounts, not a personal schedule.
| Source | Reported amount and setting | Source type | Checked |
|---|---|---|---|
| PMID 41319798 | Single subcutaneous doses: 0.5, 2, 5, 6 or 7.5 mg. The four-week cohorts studied weekly amounts within 5 to 12 mg. | Full phase 1 paper[2] | 2026-09-06 |
| EASD LBA65, NCT04838405 | Weekly subcutaneous treatment with targets of 8 mg over 12 weeks or 22 mg over 24 weeks. Some participants finished below target. | Primary meeting slides[7] | 2026-09-06 |
| DOI 10.2337/db25-763-P | A 22 mg weekly subcutaneous target over 12 weeks in the diabetes cohort. | Conference abstract[8] | 2026-09-06 |
| DOI 10.2337/db26-2813-LB, NCT06525935 | Weekly subcutaneous targets of 4, 8, 12, 16 or 24 mg over 48 weeks. | Phase 2 conference abstract[3] | 2026-09-06 |
What do animal and laboratory studies add?
Chakravarthy and his team tested how the drug acts on cells before the early human trial[2]. The cell work supports its proposed action on both receptors. Tests in mice and monkeys found effects on blood sugar. These were not human trials. Carmot paid for the work.
| Model | Finding | Boundary | Checked |
|---|---|---|---|
| Receptor and human beta-cell tests | cAMP activation at GLP-1/GIP receptors with little internalisation; enhanced glucose-stimulated insulin release[2] | Cell assays, not a clinical comparison | 2026-09-06 |
| Mouse and monkey glucose tests | Improved glucose handling[2] | Different species and doses | 2026-09-06 |
| Obesity mouse models | Less food intake and lower body weight[2] | Not a human weight-loss percentage | 2026-09-06 |
| Mouse liver-disease model | Less liver fat and liver-cell ballooning; lower ALT and AST[2] | Does not establish treatment of human liver disease | 2026-09-06 |
What is the current evidence status, and what is the regulatory status?
CT-388 has measured human results. The later phase 2 report is a meeting abstract, not a full trial paper[3]. The full phase 1 paper covers earlier, smaller groups[2]. A result does not mean a drug is approved for sale. The EU central index contains no entry under Enicepatide, CT-388 or RO7795068[13].
| Trial | Current record | Sponsor | Checked |
|---|---|---|---|
| NCT04838405 | Phase 1 completed; 129 actual enrollment across the programme; no registry results posted[10] | Carmot | 2026-09-06 |
| NCT06525935 | Phase 2 completed; 469 actual enrollment; no registry results posted[1] | Carmot; Roche collaborator | 2026-09-06 |
| NCT06628362 | Phase 2 with type 2 diabetes; active, not recruiting; 447 actual enrollment; no results posted[11] | Carmot; Roche collaborator | 2026-09-06 |
| Enith1, NCT07351045 | Phase 3 recruiting; planned enrollment 2,000; no results posted[4] | Hoffmann-La Roche | 2026-09-06 |
| Enith2, NCT07351058 | Phase 3 recruiting; planned enrollment 1,600; no results posted[12] | Hoffmann-La Roche | 2026-09-06 |
The central EU index does not cover each country's own drug list. It does not settle the UK status. No CT-388 vial-test paper was found in the bounded PubMed query[14]. No paper on CT-388 forum reports was found in the separate query[15]. These searches do not cover every product test or online post. No first-person treatment account is quoted.
See also
References
- ↑ a b c d e Carmot Therapeutics. Enicepatide phase 2 obesity study. ClinicalTrials.gov. NCT06525935. Used for names, sponsor, design, enrollment and registry status; checked 2026-09-06.
- ↑ a b c d e f g h i j k l m n o p q r s t Chakravarthy MV et al. CT-388 in preclinical models and participants with obesity. Molecular Metabolism, 2026;103:102291 (online 2025). PMID 41319798. DOI 10.1016/j.molmet.2025.102291. Used for mechanism, full phase 1 methods/results, adverse findings, doses, preclinical findings and Carmot funding; checked 2026-09-06.
- ↑ a b c d e f g h i Lingvay I et al. CT-388: a 48-week phase 2 study. Diabetes, 2026;75(Supplement_1):2813-LB. DOI 10.2337/db26-2813-LB. Used for randomized count, weight/glucose results, study doses and F. Hoffmann-La Roche funding. Meeting abstract; publisher-deposited text checked 2026-09-06.
- ↑ a b Hoffmann-La Roche. Enith1. ClinicalTrials.gov. NCT07351045. Used for phase 3 plan, size, sponsor and status; checked 2026-09-06.
- ↑ a b c FDA/NCATS. Enicepatide substance record. GSRS. UNII MTP9QR7GYF. Names, codes and modifications endpoints also checked. Used for INN, synthetic scaffold, residue count, CAS and UNII; checked 2026-09-06.
- ↑ a b c d e f g h i j k Lingvay I and Roche. ADA investor event: enicepatide phase 2 results. 8 June 2026, CT388-103 slides. NCT06525935. Used for intervals, dose groups, who stayed in the trial, safety rows and funding; checked 2026-09-06.
- ↑ a b c d e f Chakravarthy MV et al. CT-388 over 24 weeks in adults with obesity. EASD, 2024, LBA65. NCT04838405. Used for longer trial groups, results, doses, pregnancy outcomes, gut effects and Carmot/Roche funding; checked 2026-09-06.
- ↑ a b c d Steinberg A et al. CT-388 in a 12-week diabetes cohort. Diabetes, 2025;74(Supplement_1):763-P. DOI 10.2337/db25-763-P. Used for group size, weight/HbA1c findings, doses, adverse events and disclosures; checked 2026-09-06.
- ↑ a b c d Roche. Phase 2 CT-388 results in obesity. Sponsor release, 27 January 2026. NCT06525935. Used for BMI threshold and pooled treatment-stop rates; checked 2026-09-06.
- ↑ a b Carmot Therapeutics. CT-388 first-in-human programme. ClinicalTrials.gov. NCT04838405. Used for programme enrollment, sponsor and status; checked 2026-09-06.
- ↑ Carmot Therapeutics. Enicepatide with type 2 diabetes. ClinicalTrials.gov. NCT06628362. Used for phase 2 enrollment, sponsor and status; checked 2026-09-06.
- ↑ Hoffmann-La Roche. Enith2. ClinicalTrials.gov. NCT07351058. Used for phase 3 enrollment, sponsor and status; checked 2026-09-06.
- ↑ a b European Commission. Active-substance index. Union Register. Used for bounded central-register searches for Enicepatide, CT-388 and RO7795068; checked 2026-09-06.
- ↑ National Library of Medicine. CT-388 vial-testing search. PubMed search. Used for the bounded title/abstract search with vial, counterfeit and product-testing terms; checked 2026-09-06.
- ↑ National Library of Medicine. CT-388 forum-report search. PubMed search. Used for the bounded title/abstract search with forum, Reddit and self-report terms; not a census of online posts; checked 2026-09-06.