A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
NCT07670416 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-08-13
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.
Conditions
- Obesity
- Overweight
- Type 2 Diabetes Mellitus (T2DM)
Interventions
- COMBINATION_PRODUCT
-
Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
- COMBINATION_PRODUCT
-
Placebo
Participants will receive matching placebo via SC injection as per the schedule in the protocol.
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
- 2026-07-03
- Primary Completion
- 2028-02-24
- Completion
- 2028-03-15
Countries
- China
Study Locations
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