A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
NCT07351058 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600
Last updated 2026-04-24
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), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
Conditions
- Obesity or Overweight
- Type 2 Diabetes Mellitus
Interventions
- COMBINATION_PRODUCT
-
Placebo
Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
- COMBINATION_PRODUCT
-
Enicepatide
Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-23
- Primary Completion
- 2028-08-07
- Completion
- 2028-08-07
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Canada
- Japan
- Taiwan
- Thailand
Study Locations
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