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
1 other identifier
interventional
300
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Jul 2026
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedStudy Start
First participant enrolled
July 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2028
July 14, 2026
July 1, 2026
1.6 years
June 22, 2026
July 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Body Weight at Week 52
Baseline through Week 52
Secondary Outcomes (39)
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
- +34 more secondary outcomes
Study Arms (4)
Enicepatide Dose 1
EXPERIMENTALParticipants will receive enicepatide Dose 1.
Enicepatide Dose 2
EXPERIMENTALParticipants will receive enicepatide Dose 2.
Enicepatide Dose 3
EXPERIMENTALParticipants will receive enicepatide Dose 3.
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo.
Interventions
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Participants will receive matching placebo via SC injection as per the schedule in the protocol.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000, China
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
Ningbo, Zhejiang, 315010, China
Peking University People's Hospital
Beijing, 100044, China
Jinan Central Hospital
Jinan, 250013, China
Hebei Petro China Central Hospital
Langfang, 065000, China
Luoyang Third People's Hospital
Luoyang, 471000, China
Shanghai Tenth People's Hospital
Shanghai, 200072, China
Shanghai East Hospital
Shanghai, 200120, China
Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200336, China
Shanghai Fifth People's Hospital Affiliated to Fudan University
Shanghai, 201304, China
Hebei Medical University - The Second Hospital
Shijiazhuang, 050004, China
Zibo Municipal Hospital.
Zibo, 255400, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2026
First Posted
June 26, 2026
Study Start
July 3, 2026
Primary Completion (Estimated)
February 24, 2028
Study Completion (Estimated)
March 15, 2028
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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