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

Korábbi kezelés

• 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)

Más betegség

• 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

Egyéb

• 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)

• 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