Enicepatide: trials, results, and current status.
Also searched as CT-388 · RO7795068 · RG6640
Enicepatide, formerly CT-388, is Roche's investigational once-weekly dual GLP-1 and GIP receptor agonist for chronic weight management and related metabolic conditions. A completed Phase 2 study now has sponsor-reported 48-week results, while two recruiting Phase 3 ENITH trials test the program in people with and without type 2 diabetes. Neither milestone is an approval or a commercial product record.
Is enicepatide in Phase 3 or available to buy?
Enicepatide is in a recruiting Phase 3 program. ENITH-1 lists 2,000 estimated participants with obesity or overweight without type 2 diabetes, and ENITH-2 lists 1,600 with type 2 diabetes. Both records began in March 2026 and currently estimate primary completion in 2028. Enicepatide is not FDA approved and has no legitimate approved retail product, label, pharmacy price, or prescribing route. Recruiting status should never be interpreted as approval or proof that an online vial is authentic clinical material.
Compare Enicepatide with Retatrutide, without losing the country context.
Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.
Investigational clinical program
Official product and seller records attached
Investigational clinical program
What can you conclude about Enicepatide today?
These are dated program facts, not a cross-trial ranking, approval forecast, personal treatment recommendation, or proof that a same-name online product is the sponsor's medicine.
Clinical records also list RG6640, while newer Roche materials use enicepatide.
Sponsor-reported efficacy-estimand result at week 48 for the 24 mg group; the treatment-regimen estimate was 18.3%.
Sponsor-reported discontinuation due to adverse events across enicepatide arms versus placebo in CT388-103.
ENITH-1 and ENITH-2 list estimated enrollments of 2,000 and 1,600 participants, respectively.
Know which molecule the result belongs to.
- Sponsor
- Roche / Carmot Therapeutics
- Mechanism
- Signal-biased GLP-1 + GIP receptor dual agonist
- Route being studied
- Once-weekly subcutaneous injection
- Current stage
- Phase 3 ENITH program recruiting
- Featured trial anchors
- NCT06525935 · NCT07351045 · NCT07351058 · NCT04838405
- Evidence checked
- July 18, 2026
Enicepatide weight-loss results, with the trial attached.
This visual shows one selected result, not every dose or endpoint in the program. The percentage remains attached to its duration, population, comparator, analysis method, and source.
Evidence checked July 21, 2026Enicepatide reported a 22.5% placebo-adjusted difference at 48 weeks under the placebo-adjusted efficacy estimate.
Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.
- Population
- Adults with obesity or overweight and at least one complication
- Participants
- 469 Total randomized dose-finding trial population
- Dose
- 24 mg, highest tested dose
- Primary analysis
- Placebo-adjusted efficacy estimate
- Alternate analysis
- Placebo-adjusted treatment-regimen estimate
- Regulatory status
- Investigational; not FDA approved
Enicepatide clinical trials by status, phase, and location.
The current exact-intervention snapshot matches 8 unique NCT records. This chart describes registry coverage and current study fields. It does not compare efficacy, safety, approval probability, eligibility, or treatment access.
Snapshot 2026-07-24Counts use individual locations currently marked Recruiting, not every facility listed on an overall-recruiting study. Repeated centers across studies remain repeated site observations.
Enicepatide across 42 countries.
This profile establishes the program identity and its cited clinical or regulatory record. It does not turn a same-name seller listing into the sponsor’s asset or prove authorization, availability, or lawful supply in another destination.
Compare Enicepatide by country →Compare Enicepatide by US state →Browse the global peptide country dataset →Is Enicepatide approved or available in your country?
Start with the United States FDA record, then check the destination that matters to you. Each country page separates drug identity, authorization, product records, seller claims, and supply rules. Directory checked July 20, 2026.
What the record shows - and what it doesn’t.
Trial percentages are kept beside the design details that make them interpretable. Unknowns stay visible instead of being filled with launch speculation.
CT388-103 completed its 48-week Phase 2 design
ClinicalTrials.gov records 469 actual participants in a randomized, double-blind, placebo-controlled dose-finding trial without type 2 diabetes. Roche reported 22.5% placebo-adjusted weight loss at the highest tested dose under the efficacy estimand and 18.3% under the treatment-regimen estimand at week 48.
Tolerability needs the exact denominator and endpoint
Roche reported that most gastrointestinal adverse events were mild to moderate and that discontinuation due to adverse events was 5.9% across enicepatide arms versus 1.3% with placebo. That sponsor summary does not establish superiority over another medicine or replace full dose-level event tables and later peer-reviewed Phase 2 publication.
The ENITH program is recruiting
ENITH-1 studies obesity or overweight without type 2 diabetes over a planned 72-week primary period, while ENITH-2 studies a population with type 2 diabetes. The current records list actual March 2026 starts and estimated enrollments, with primary completion dates in 2028 rather than available Phase 3 outcomes.
Phase 3 outcomes are not available
Recruiting trials establish that the pivotal program has started, not that efficacy, safety, tolerability, durability, or benefit-risk outcomes have been demonstrated. Estimated enrollment and completion dates can also change as records are updated.
No approved label or commercial route
Enicepatide has no FDA-approved indication, final dose, prescribing information, retail price, pharmacy channel, or coverage policy. An online listing using enicepatide, CT-388, RO7795068, or RG6640 does not become Roche clinical material by sharing a name.
Cross-trial rankings remain unsupported
The 22.5% placebo-adjusted efficacy estimate cannot be ranked fairly against another program's result without matching population, duration, dose, estimand, placebo response, adherence assumptions, rescue treatment, missing data, and adverse-event reporting.
The questions behind the search.
Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.
What is enicepatide, and is it the same as CT-388?
Yes. Enicepatide is the newer name used for the investigational molecule previously called CT-388. ClinicalTrials.gov also connects the program to RO7795068 and RG6640. It is a peptide-based, signal-biased dual agonist designed to activate GLP-1 and GIP receptors with once-weekly subcutaneous dosing under study. The linked names resolve an evidence trail; they do not identify an approved medicine, an authentic retail formulation, or a dosing instruction for consumers.
What did the enicepatide Phase 2 trial show?
CT388-103 randomized 469 adults with obesity or overweight and a weight-related condition, without type 2 diabetes, to several enicepatide dosing strategies or placebo for 48 weeks. Roche reported 22.5% placebo-adjusted weight loss for the highest tested dose under the efficacy estimand and 18.3% under the treatment-regimen estimand. It also reported adverse-event discontinuation of 5.9% across enicepatide arms versus 1.3% with placebo. These sponsor results are substantial, but they are not a head-to-head comparison with tirzepatide, retatrutide, or another program.
Is enicepatide in Phase 3 or available to buy?
Enicepatide is in a recruiting Phase 3 program. ENITH-1 lists 2,000 estimated participants with obesity or overweight without type 2 diabetes, and ENITH-2 lists 1,600 with type 2 diabetes. Both records began in March 2026 and currently estimate primary completion in 2028. Enicepatide is not FDA approved and has no legitimate approved retail product, label, pharmacy price, or prescribing route. Recruiting status should never be interpreted as approval or proof that an online vial is authentic clinical material.
Do not use an investigational name, trial dose, or online research listing as a substitute for approved care. This page does not recommend treatment, sourcing, or participation in a clinical trial.
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