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
Public ClinicalTrials.gov record NCT06965413. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06965413
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 285 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 5, 2025 (Actual)
- Primary completion
- Sep 3, 2026 (Actual)
- Completion
- Mar 31, 2027 (Estimated)
- Last update posted
- Sep 9, 2026
2025 – 2027
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | — |
| Encompass Clinical Research | Spring Valley | California | 91978 | — |
| K2 Medical Research-Winter Garden | Clermont | Florida | 34711 | — |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | — |
| Accellacare of Duly Health and Care | Oak Lawn | Illinois | 60453 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Accellacare of Salisbury | Salisbury | North Carolina | 28144 | — |
| Accellacare of Piedmont Healthcare | Statesville | North Carolina | 28625 | — |
| Accellacare of Wilmington, LLC | Wilmington | North Carolina | 28401 | — |
| Accellacare Research of Winston Salem | Winston-Salem | North Carolina | 27103 | — |
| NexGen Research | Lima | Ohio | 45801 | — |
| Accellacare of Bristol/ Internal Medicine & Pediatrics | Bristol | Tennessee | 37620 | — |
| Accellacare of Knoxville | Knoxville | Tennessee | 37912 | — |
| Clinical Research Associates | Nashville | Tennessee | 37203 | — |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78731 | — |
| Juno Research, LLC | Houston | Texas | 77040 | — |
| Consano Clinical Research | Shavano Park | Texas | 78231 | — |
| Velocity Clinical Research (Impact Research Institute) | Waco | Texas | 76710 | — |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06965413, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06965413 live on ClinicalTrials.gov.