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NCT06965413 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study of Obesity and Overweight, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 2
- Development phase
- 285
- Enrollment target
- 20
- Study locations
NCT06965413 is a Phase 2 study of Obesity and Overweight that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 285 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT06965413, a Phase 2 study of Obesity and Overweight, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 285 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Tirzepatide
- DRUG RO7204239
- DRUG RO7204239 Matching Placebo
Study Locations (20)
North Carolina
- Accellacare of Salisbury - Salisbury
- Accellacare of Piedmont Healthcare - Statesville
- Accellacare of Wilmington, LLC - Wilmington
- Accellacare Research of Winston Salem - Winston-Salem
Texas
- Texas Diabetes & Endocrinology, P.A. - Austin
- Juno Research, LLC - Houston
- Consano Clinical Research - Shavano Park
- Velocity Clinical Research (Impact Research Institute) - Waco
Tennessee
- Accellacare of Bristol/ Internal Medicine & Pediatrics - Bristol
- Accellacare of Knoxville - Knoxville
- Clinical Research Associates - Nashville
Alabama
- Pinnacle Research Group - Anniston
California
- Encompass Clinical Research - Spring Valley
Florida
- K2 Medical Research-Winter Garden - Clermont
Georgia
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City
Illinois
- Accellacare of Duly Health and Care - Oak Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2025-05-05 |
| Est. Completion | 2027-07-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06965413
The ClinicalTrials.gov registry entry for NCT06965413 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 285 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (65% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Tirzepatide is the first listed.
NCT06965413 reports 20 study locations spanning 12 distinct geographic areas - top geographies include North Carolina, Texas, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06965413 about?
NCT06965413 is a clinical study titled "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". 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...
What is the current status of trial NCT06965413?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 285 participants. The study started on 2025-05-05. Estimated completion is 2027-07-23.
What conditions does trial NCT06965413 study?
This clinical trial studies the following conditions: Obesity, Overweight, Overweight With One Weight Related Comorbidity.
What interventions are being tested in trial NCT06965413?
The interventions under investigation include: Tirzepatide (DRUG), RO7204239 (DRUG), RO7204239 Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT06965413?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06965413 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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