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

NCT06965413 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing the safety and effects of the experimental drug RO7204239 combined with tirzepatide on body weight in adults who are overweight or have obesity with at least one related health condition.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 285 people

Who can join Ages 18+ · all sexes

Timeline Started 2025-05 · est. completion 2027-07

Where 35 sites · Poland, Spain, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT06965413 ↗

Description as written by the study sponsor.

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.

Treatments tested

RO7204239 Drug

RO7204239 or matching placebo will be administered as per the schedule specified in the arms.
RO7204239 Matching Placebo Drug

RO7204239 matching placebo will be administered as per the schedule specified in the arm.
Tirzepatide Drug

Tirzepatide will be administered as per the schedule specified in the arms.

Main thing measured	Percent Change From Baseline in Body Weight
Sponsor	Hoffmann-La Roche
Conditions studied	Obesity, Overweight, Overweight With One Weight Related Comorbidity
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06965413 ↗