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RecruitingPhase 3

A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus

Lead sponsor

Hoffmann-La Roche

Asset

CT-388

Subcutaneous · GLP-1 / GIP dual

Listed sites

3

Recruiting sites

3

Estimated enrollment

300

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥24

Primary endpoint

•Body Weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07670416
Org study IDYC46401

Timeline

Milestones

Study start2026-06-25estimated
Study first posted2026-06-26actual
Last update posted2026-06-26actual
Primary completion2028-03-12estimated
Study completion2028-04-02estimated

Assets

Investigational agents

CT-388

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
•Agreement to adhere to the contraception requirements

Exclusion criteria

•History of Type 1 diabetes mellitus (T1DM)
•Obesity induced by other endocrinologic disorders
•Any planned major medical procedure or surgery during the study
•History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
•Any lifetime history of suicide attempt
•History of any hematologic conditions that may interfere with HbA1c measurement
•History of acute or chronic pancreatitis or clinically significant gallbladder disease
•Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
•Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
•Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs

Endpoints (40)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
16
Cardiometabolic biomarkers
11
Glycemic / diabetes
5
Patient-reported / QoL
4
Safety / tolerability / PK
2
Other (unclassified)
2

Weight & body composition

16 endpoints
Primary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 52

Time frame:Baseline through Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52

Time frame:At Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52

Time frame:At Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52

Time frame:At Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3

Time frame:At Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Physical Functioning Composite Score as Assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations

Time frame:Baseline through Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist-to-Hip Ratio at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist-to-Height Ratio at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3

Time frame:Baseline through Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight by Obesity Class at Week 52

Time frame:Baseline through Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Adipose Tissue Volume at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Total Adipose Tissue Volume at Week 52

Time frame:Baseline through Week 52

percent change from baseline, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

Change From Baseline in Fasting Glucose at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Insulin at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52

Time frame:At Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in HbA1c at Week 52 in Participants With T2DM

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52

Time frame:At Week 52

threshold achievement, improvement

Cardiometabolic biomarkers

11 endpoints
Secondary/protocol endpoint

Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Triglyceride at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Non-HDL Cholesterol at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Free Fatty Acids at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Serum Uric Acid at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Patient-reported / QoL

4 endpoints
Secondary/protocol endpoint

Change From Baseline in the Physical Functioning as Assessed by Short Form 36 Health Survey Acute, Version 2.0 (SF-36 v2 Acute) at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Domain Scores and Component Summary Scores at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score

Time frame:Baseline through Week 52

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria

Time frame:Baseline to Safety Follow-Up (55 Weeks)

descriptive

Secondary/protocol endpoint

Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Time frame:Baseline through Week 52

change from baseline, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change From Baseline in Total Lean Tissue Volume at Week 52

Time frame:Baseline through Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percent Change From Baseline in Total Lean Tissue Volume at Week 52

Time frame:Baseline through Week 52

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.