NCT06965413Active, not recruitingPhase 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 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
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 285 (actual)
- First submitted
- 2 May 2025
- Start date
- 5 May 2025
- Primary completion date
- 3 Sept 2026
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Obesity
- NCT number
- NCT06965413
- EU CT number
- 2024-519561-22-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 285
- From 5 May 2025 to the primary completion date, 3 Sept 2026
- 40 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history or diagnosis of DM
- Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema
- Prior or planned surgical treatment for obesity
- Endoscopic and/or device-based therapy for obesity or device removal within 6 months prior to screening
- Have any of the following cardiovascular conditions within 6 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF)
Other illness
- Have obesity induced by other endocrinologic disorders
- Have evidence of significant active, uncontrolled cardiovascular, autoimmune, endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, a neurological or psychiatric condition, or a history of any neuromuscular disorder or autoimmune/inflammatory disorders that may cause muscle wasting or medical condition capable of constituting a risk when taking the study medication or interfering with the interpretation of data, as judged by the investigator at screening
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy
- Have evidence of a significant, active autoimmune abnormality
- Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease
Other
- Participation in unbalanced/extreme diets
- Have a known clinically significant gastric emptying abnormality
- Have evidence of a significant, uncontrolled endocrine abnormality
- Have anemia
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
Who the study is looking for
- BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-related comorbidities are not required for inclusion)
- BMI ≥ 27.0 kg/m² and \< 30.0 kg/m² with at least one weight-related comorbidity such as: hypertension, dyslipidemia, obstructive sleep apnea and any cardiovascular disease
- History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight
- Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11 pounds \[lbs\]) within 3 months prior to screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Medico Quirurgico San Rafael S.A. Coordinator of this site? Confirm its status | A Coruna | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Nisa Sevilla Aljarafe Coordinator of this site? Confirm its status | Castilleja De La Cuesta | Spain | Active, not recruiting |
| Area Sanitaria De Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Fylde Coast Clinical Research at Layton Medical Centre Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Unknown status |
| Accellacare Warwickshire Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH) Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Accellacare North London Coordinator of this site? Confirm its status | Northwood | United Kingdom | Unknown status |
| Accellacare South London Coordinator of this site? Confirm its status | Orpington | United Kingdom | Unknown status |
| Accellacare Yorkshire Coordinator of this site? Confirm its status | Shipley | United Kingdom | Unknown status |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| EKAMED sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Etg Warszawa Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Pinnacle Research Group Coordinator of this site? Confirm its status | Anniston | United States | Unknown status |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Accellacare of Bristol/ Internal Medicine & Pediatrics Coordinator of this site? Confirm its status | Bristol | United States | Unknown status |
| K2 Medical Research WINTER GARDEN Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Juno Research, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Accellacare of Knoxville Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| NexGen Research Coordinator of this site? Confirm its status | Lima | United States | Unknown status |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Clinical Research Associates Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Accellacare of Duly Health and Care Coordinator of this site? Confirm its status | Oak Lawn | United States | Unknown status |
| Rochester Clinical Research Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Accellacare of Salisbury Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| Consano Clinical Research Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Encompass Clinical Research Coordinator of this site? Confirm its status | Spring Valley | United States | Unknown status |
| Accellacare of Piedmont HealthCare Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| Rophe Adult and Pediatric Medicine/SKYCRNG Coordinator of this site? Confirm its status | Union City | United States | Unknown status |
| Velocity Clinical Research (Impact Research Institute) Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| Accellacare of Wilmington, LLC Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Accellacare Research of Winston Salem Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.