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

Launched by HOFFMANN-LA ROCHE · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults who are overweight or have obesity, especially those who also have weight-related health issues like high blood pressure or sleep apnea. The main goal is to see how well a medication called RO7204239 works when combined with another medication called tirzepatide, compared to a placebo (a dummy treatment) along with tirzepatide. The study will last for a total of 72 weeks, including a 4-week screening period to determine if participants are eligible, a 48-week treatment phase, and then 24 weeks of follow-up after stopping the medication.

To be eligible for this trial, participants should have a body mass index (BMI) of 27 or higher, and they must have tried to lose weight unsuccessfully through diet or exercise before. However, they cannot have diabetes or certain other serious health conditions. If you decide to take part, you will receive tirzepatide throughout the study, and depending on which group you are assigned to, you may also receive RO7204239 or a placebo. This trial is currently recruiting participants, so if you think you might be eligible, it could be a good opportunity to contribute to important research while potentially benefiting your health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)