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Not Yet Recruiting NCT07589686

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

Conditions: Obesity or Overweight

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 486
Sponsor: Hoffmann-La Roche

Summary

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07589686). StuddyBuddy aggregates publicly available trial information.