Not yet recruiting NCT07589686
A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Petrelintide, Enicepatide, Petrelintide-matching Placebo, Enicepatide-matching Placebo.
- Who it may be relevant to
- Registry conditions: Obesity or Overweight. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Petrelintide
Petrelintide will be administered subcutaneously to participants once weekly - Combination product Enicepatide
Enicepatide will be administered subcutaneously to participants once weekly - Drug Petrelintide-matching Placebo
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly - Combination product Enicepatide-matching Placebo
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
Primary outcome measures
- Percentage Change in Body Weight between Arms 1 and 6 [Time frame: From Baseline to Week 40]
Secondary outcome measures (12)
- Percentage Change in Body Weight between Arms 2, 3 and Arm 6 [Time frame: From Baseline to Week 40]
- Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5 [Time frame: From Baseline to Week 40]
- Percentage of Participants Achieving Body Weight Loss [Time frame: From Baseline to Week 40]
- Change in Body Weight (kilograms [kg]) [Time frame: From Baseline to Week 40]
- Change in Body Mass Index (kilograms per square meter [kg/m²]) [Time frame: From Baseline to Week 40]
- Change in Waist Circumference (centimeter [cm]) [Time frame: From Baseline to Week 40]
- Change in Hemoglobin A1c (HbA1c) (percentage-points) [Time frame: From Baseline to Week 40]
- Change in Fasting Insulin [Time frame: From Baseline to Week 40]
- Change in Fasting Glucose [Time frame: From Baseline to Week 40]
- Change in Systolic Blood Pressure [Time frame: From Baseline to Week 40]
- Change in Diastolic Blood Pressure [Time frame: From Baseline to Week 40]
- Change in High-Density Lipoprotein (HDL) Cholesterol [Time frame: From Baseline to Week 40]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07589686 · CC46372