Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Prior history or diagnosis of DM
- Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema
- Have obesity induced by other endocrinologic disorders
- Participation in unbalanced/extreme diets
- 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 a known clinically significant gastric emptying abnormality
- 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)
- 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 evidence of a significant, uncontrolled endocrine abnormality
- 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 anemia
- Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2027
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT06965413
Start Date
May 5 2025
End Date
July 24 2027
Last Update
November 12 2025
Active Locations (35)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Encompass Clinical Research
Spring Valley, California, United States, 91978
3
K2 Medical Research South Orlando, LLC
Orlando, Florida, United States, 32806
4
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States, 30291