Drug evidence profileInvestigational - not FDA approved

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.

Approval and access

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.

Live decision workspace

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.

AIdentity record
Enicepatide

Investigational clinical program

No linked research price board
Destination fixedUnited StatesNorth America

Official product and seller records attached

BComparison record
Retatrutide

Investigational clinical program

No linked research price board
01 · Status02 · Trials03 · Country04 · Price
Current program snapshot

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.

Former namesCT-388 / RO7795068

Clinical records also list RG6640, while newer Roche materials use enicepatide.

Phase 2 efficacy22.5% placebo-adjusted

Sponsor-reported efficacy-estimand result at week 48 for the 24 mg group; the treatment-regimen estimate was 18.3%.

AE discontinuation5.9% vs 1.3%

Sponsor-reported discontinuation due to adverse events across enicepatide arms versus placebo in CT388-103.

Current stageTwo recruiting Phase 3 trials

ENITH-1 and ENITH-2 list estimated enrollments of 2,000 and 1,600 participants, respectively.

Marketing and authorization statusInvestigational - not FDA approved
Evidence checked July 18, 2026Open lead source
Program identity

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
Sourced weight-loss trial results

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, 2026
Phase 2Weekly injection
NCT06525935
22.5%Placebo-adjusted difference
CT388-10348 weeks

Enicepatide reported a 22.5% placebo-adjusted difference at 48 weeks under the placebo-adjusted efficacy estimate.

Placebo-adjusted difference22.5%
Alternate analysis18.3%

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
ClinicalTrials.gov program landscape

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 2026-07-24
8matched NCT records
4overall Recruiting
0registry results posted
339recruiting site observations
23countries with recruiting sites
Registry phase mix3 phase labels
Phase labels come from ClinicalTrials.gov. A larger phase count is not stronger evidence or a better program.
Registry geographyTop current recruiting-site observations

Counts use individual locations currently marked Recruiting, not every facility listed on an overall-recruiting study. Repeated centers across studies remain repeated site observations.

Countries24 represented
01United States2 recruiting studies71 sites02China4 recruiting studies47 sites03Poland2 recruiting studies20 sites04Germany2 recruiting studies18 sites05Spain2 recruiting studies18 sites06United Kingdom2 recruiting studies18 sites
United States34 states represented
01Texas2 recruiting studies16 sites02California2 recruiting studies7 sites03Alabama2 recruiting studies4 sites04Oklahoma2 recruiting studies4 sites05Florida1 recruiting study4 sites06Georgia2 recruiting studies3 sites
Worldwide status map

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 →
Country-specific status checks

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.

Evidence ledger

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.

Supported
01

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.

02

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.

03

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.

Not established
01

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.

02

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.

03

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.

Direct answers

The questions behind the search.

Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.

01

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.

02

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.

03

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.

Important boundaryApproval status is jurisdiction-specific.

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.

Understand the product-category boundary →
Primary referencesCT388-103 Phase 2 results48-week efficacy estimands, dose context, adverse-event discontinuation, mechanism, and development planRoche · January 27, 2026CT388-103 Phase 2 study - NCT06525935Completed randomized design, actual enrollment, population, route, intervention aliases, and endpointsClinicalTrials.gov · Record checked July 18, 2026ENITH-1 Phase 3 study - NCT07351045Recruiting status, Phase 3 design, estimated enrollment, actual start, aliases, and completion timingClinicalTrials.gov · Record checked July 18, 2026ENITH-2 Phase 3 study - NCT07351058Type 2 diabetes population, recruiting status, Phase 3 design, estimated enrollment, and timingClinicalTrials.gov · Record checked July 18, 2026CT-388 mechanism and Phase 1 clinical evidencePeptide identity, signal-biased dual receptor design, Phase 1 methods, pharmacokinetics, and once-weekly rationalePubMed / Molecular Metabolism · January 2026Enicepatide and petrelintide development updateCurrent enicepatide naming, Phase 2 program, Phase 3 development, and combination-study contextRoche · June 1, 2026