Recent Updates
Recently added Catalysts

Enicepatide

Phase 3

Obesity | Small molecule | Metabolic |Roche Holding AG|Last Updated: Aug 14, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment769

FDA Designations

No designations recorded

Clinical trial landscape

Enicepatide · 5 trials · 6 indications

Phase 3 3Phase 2 1Phase 1 1
NCT07670416A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 DiabetesObesity
RECRUITING300 Analytics
NCT07351058A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 DiabetesObesity or Overweight
RECRUITING1,600 Analytics
NCT07351045A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 DiabetesObesity or Overweight
RECRUITING2,000 Analytics
PHASE3RECRUITING
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
ObesityUnlock trial analytics
PHASE3RECRUITING
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Obesity or OverweightUnlock trial analytics
PHASE3RECRUITING
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
Obesity or OverweightUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Body Weight at Week 52
Baseline through Week 52
Percent (%) Change from Baseline in Body Weight at Week 72
Baseline through Week 72
Percent Change in Body Weight from Baseline to Week 48
Baseline to Week 48
Incidence and Severity of Adverse Events
Baseline to Safety Follow-Up (27 weeks)
Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade
Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Pulse Rate
At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Respiratory Rate
At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Systolic Blood Pressure
At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Diastolic Blood Pressure
At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Body Temperature
At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

Secondary Endpoints

Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
At Week 52
Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52
At Week 52
Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52
At Week 52
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Enicepatide Dose 1EXPERIMENTALParticipants will receive enicepatide Dose 1.
Enicepatide Dose 2EXPERIMENTALParticipants will receive enicepatide Dose 2.
Enicepatide Dose 3EXPERIMENTALParticipants will receive enicepatide Dose 3.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo.
Arm 1: PlaceboPLACEBO_COMPARATOR -
Arm 2: Enicepatide Dosing Regimen 1EXPERIMENTAL -
Arm 3: Enicepatide Dosing Regimen 2EXPERIMENTAL -
Arm 4: Enicepatide Dosing Regimen 3EXPERIMENTAL -
Arm 2: Enicepatide Dose Level 1 (Low)EXPERIMENTALEnicepatide Dose Level 1 administered SC once weekly.
Arm 3: Enicepatide Dose Level 2EXPERIMENTALEnicepatide Dose Level 2 administered SC once weekly.
Arm 4: Enicepatide Dose Level 3EXPERIMENTALEnicepatide Dose Level 3 administered SC once weekly.
Arm 5: Enicepatide Dose Level 4EXPERIMENTALEnicepatide Dose Level 4 administered SC once weekly.
Arm 6: Enicepatide Dose Level 5 (High)EXPERIMENTALEnicepatide Dose Level 5 administered SC once weekly.

Interventions

NameTypeDescription
EnicepatideCOMBINATION_PRODUCTParticipants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
PlaceboCOMBINATION_PRODUCTParticipants will receive matching placebo via SC injection as per the schedule in the protocol.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m\^2) for participants with type 2 diabetes mellitus (T2DM) * BMI ≥28.0 kg/m\^2 or BMI ≥24.0 and \<28.0 kg/m\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatt...

Countries:ChinaUnited StatesArgentinaAustraliaBrazilCanadaCzechiaFranceGermanyItalyJapanMexicoPolandPuerto RicoSouth KoreaSpainTaiwanThailandTurkey (Türkiye)United KingdomBelgiumHungaryNetherlands
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07351045lastUpdatePostDate: changed
LOWAug 14, 2026NCT07670416lastUpdatePostDate: changed
LOWAug 14, 2026NCT07351058lastUpdatePostDate: changed
LOWAug 14, 2026NCT07351045lastUpdatePostDate: changed
LOWAug 14, 2026NCT07670416lastUpdatePostDate: changed
LOWAug 14, 2026NCT07351058lastUpdatePostDate: changed
LOWAug 14, 2026NCT07670416lastUpdatePostDate: changed
LOWAug 11, 2026NCT07626515primaryCompletionDate: changed
LOWAug 11, 2026NCT07626515primaryCompletionDate: changed
LOWAug 11, 2026NCT07626515primaryCompletionDate: changed
LOWAug 1, 2026NCT07351058lastUpdatePostDate: changed
LOWAug 1, 2026NCT07626515Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 1, 2026NCT07351058lastUpdatePostDate: changed
LOWAug 1, 2026NCT07626515Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 1, 2026NCT07351058lastUpdatePostDate: changed
LOWAug 1, 2026NCT07626515Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about Enicepatide

What is Enicepatide used for?

Enicepatide is an investigational small molecule being developed for obesity or overweight, including in people with weight-related comorbidities or type 2 diabetes. It is being studied in participants with obesity or overweight, with or without type 2 diabetes, and is not yet approved for any use.

What does Enicepatide target?

Enicepatide is a peptide-based small molecule, classified under the -tide (peptide) target class. Its specific molecular target is not disclosed in the available information. It is being studied for its effects on weight in people with obesity or overweight.

Who is developing Enicepatide?

Enicepatide is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's effects in participants with obesity or overweight, with or without type 2 diabetes.

What phase is Enicepatide in?

Enicepatide is in Phase 3 clinical development. It has completed a Phase 2 trial and is currently being evaluated in multiple Phase 3 trials. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is Enicepatide in?

Enicepatide is being studied in several Phase 3 trials, including NCT07351045 in participants with obesity or overweight without type 2 diabetes, NCT07351058 in those with type 2 diabetes, and NCT07670416 in China. A Phase 2 trial, NCT06525935, has been completed.

Is Enicepatide the same as CT-388?

Yes, Enicepatide is also known as CT-388, as indicated in the Phase 2 trial title. It is also referred to as RO7795068 in Phase 3 trial titles. These names refer to the same investigational drug being developed by Roche.