Trials / Active Not Recruiting
Active Not RecruitingNCT06965413
A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity
A Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Assess Efficacy, Safety, and Tolerability of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 285 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RO7204239 | RO7204239 or matching placebo will be administered as per the schedule specified in the arms. |
| DRUG | RO7204239 Matching Placebo | RO7204239 matching placebo will be administered as per the schedule specified in the arm. |
| DRUG | Tirzepatide | Tirzepatide will be administered as per the schedule specified in the arms. |
Timeline
- Start date
- 2025-05-05
- Primary completion
- 2026-08-24
- Completion
- 2027-07-23
- First posted
- 2025-05-11
- Last updated
- 2026-02-12
Locations
35 sites across 4 countries: United States, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06965413. Inclusion in this directory is not an endorsement.