Clinical trial

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

Opening soon · Phase 2 · 0 countries · Registry ID NCT07589686

Opening soonPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity or Overweight

Full registry 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

Treatments and study arms

Petrelintide

Drug

Petrelintide will be administered subcutaneously to participants once weekly

Enicepatide

Combination Product

Enicepatide will be administered subcutaneously to participants once weekly

Petrelintide-matching Placebo

Drug

Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly

Enicepatide-matching Placebo

Combination Product

Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly

Primary outcomes

Percentage Change in Body Weight between Arms 1 and 6From Baseline to Week 40

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.