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

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight; Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Combination product: Enicepatide; Combination product: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
• Study Contact Backup: Name: Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• China
  • Beijing, China, 100044
    • Recruiting
    • Peking University People's Hospital
  • Shanghai, China, 201304
    • Recruiting
    • Shanghai Fifth People's Hospital affiliated to Fudan University
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive matching placebo.	Combination product: Placebo; Participants will receive matching placebo via SC injection as per the schedule in the protocol.
Experimental: Enicepatide Dose 1; Participants will receive enicepatide Dose 1.	Combination product: Enicepatide; Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.; Other Names: RO7795068; RG6640; CT-388
Experimental: Enicepatide Dose 2; Participants will receive enicepatide Dose 2.	Combination product: Enicepatide; Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.; Other Names: RO7795068; RG6640; CT-388
Experimental: Enicepatide Dose 3; Participants will receive enicepatide Dose 3.	Combination product: Enicepatide; Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.; Other Names: RO7795068; RG6640; CT-388

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Body Weight at Week 52	Baseline through Week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3	At Week 52
Change From Baseline in Body Weight at Week 52	Baseline through Week 52
Change From Baseline in Waist Circumference at Week 52	Baseline through Week 52
Change From Baseline in Fasting Glucose at Week 52	Baseline through Week 52
Change From Baseline in Fasting Insulin at Week 52	Baseline through Week 52
Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52	Baseline through Week 52
Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52	Baseline through Week 52
Change From Baseline in Triglyceride at Week 52	Baseline through Week 52
Change From Baseline in Systolic Blood Pressure at Week 52	Baseline through Week 52
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	Baseline through Week 52
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	Baseline through Week 52
Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations	Baseline through Week 52
Change From Baseline in Waist-to-Hip Ratio at Week 52	Baseline through Week 52
Change From Baseline in Waist-to-Height Ratio at Week 52	Baseline through Week 52
Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52	At Week 52
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	Baseline through Week 52
Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52	Baseline through Week 52
Change From Baseline in Non-HDL Cholesterol at Week 52	Baseline through Week 52
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52	Baseline through Week 52
Change From Baseline in Total Cholesterol at Week 52	Baseline through Week 52
Change From Baseline in Free Fatty Acids at Week 52	Baseline through Week 52
Change From Baseline in Diastolic Blood Pressure at Week 52	Baseline through Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52	Baseline through Week 52
Change From Baseline in Serum Uric Acid at Week 52	Baseline through Week 52
Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3	Baseline through Week 52
Change From Baseline in Body Mass Index (BMI) at Week 52	Baseline through Week 52
Percent Change From Baseline in Body Weight by Obesity Class at Week 52	Baseline through Week 52
Change From Baseline in HbA1c at Week 52 in Participants With T2DM	Baseline through Week 52
Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52	At Week 52
Change From Baseline in Total Lean Tissue Volume at Week 52	Baseline through Week 52
Percent Change From Baseline in Total Lean Tissue Volume at Week 52	Baseline through Week 52
Change From Baseline in Total Adipose Tissue Volume at Week 52	Baseline through Week 52
Percent Change From Baseline in Total Adipose Tissue Volume at Week 52	Baseline through Week 52
Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria	Baseline to Safety Follow-Up (55 Weeks)
Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score	Baseline through Week 52
Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score	Baseline through Week 52

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): March 12, 2028
• Study Completion (Estimated): April 2, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: YC46401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No