Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Obesity and Overweight, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT06965413 still lists
NCT06965413 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (65% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06965413's enrollment target sits among peer trials
285 237th of 1053 higher than 817 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation
RECRUITING · Phase 2
-
Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity
RECRUITING · Phase 2
-
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
RECRUITING · Phase 2
-
Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
RECRUITING · Phase 2
-
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
RECRUITING · Phase 2
-
Pharmacological and Behavioral Treatment After Bariatric Surgery
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03412877 · 285 participants · Phase 2
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
- NCT04537936 · 285 participants · NA
Psychotherapy Intervention for Latinos With Adv Cancer
- NCT04965675 · 285 participants · Phase 3
A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
- NCT05320835 · 285 participants · NA
A Setting Focus Overdose Prevention Intervention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI