NCT07589686Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 486 (estimated)
- First submitted
- 11 May 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 12 Nov 2027
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Obesity
- NCT number
- NCT07589686
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 486
- From 30 Nov 2026 to the primary completion date, 12 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of Type 1 or Type 2 Diabetes
- Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity
- History of severe psychiatric disorders
- New York Heart Association Functional Classification IV heart failure
Lab values
- HbA1c ≥ 48 mmol/mol (6.5%) at screening
- History of any hematologic conditions that may interfere with HbA1c measurement
Other
- Known history or presence of pancreatitis
- Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.