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

Not Yet RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Obesity or Overweight

Interventions: Petrelintide, Enicepatide, Petrelintide-matching Placebo, Enicepatide-matching Placebo

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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