A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Petrelintide Co-Administered With RO7795068 in Adults With Obesity or Overweight

The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.

Key Inclusion Criteria:

• Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to < 30 kg/m² with at least one weight-related comorbidity
• History of at least one self-reported unsuccessful dietary effort to lose body weight

Key Exclusion Criteria:

• HbA1c ≥ 48 mmol/mol (6.5%) at screening
• History of Type 1 or Type 2 Diabetes
• Self-reported change in body weight > 5 kg within 90 days prior to screening
• Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed > 1 year prior to or during screening)
• Previous or planned endoscopic and/or device-based obesity treatment or removal or device within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal endoluminal liner)
• Treatment with any GLP-1 receptor agonist, GLP-1/GIP receptor agonist (or any other GLP-1 based treatment) within 180 days prior to or during screening
• Current or previous treatment with petrelintide or any other amylin analog
• Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity
• History of severe psychiatric disorders
• History of any hematologic conditions that may interfere with HbA1c measurement
• Known history or presence of pancreatitis
• Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility
• New York Heart Association Functional Classification IV heart failure
• Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required