A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight
- 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.
- Acronym
- ZYNERGY
- Short title
- A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2028-01-31
- First posted
- 2026-05-15
- Registry last updated
- 2026-08-07
- Primary completion date
- 2027-11-12
- Start date
- 2026-09-30
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Hoffmann-La Roche
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07589686
- ClinicalTrials.gov ID
- NCT07589686
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percentage Change in Body Weight between Arms 1 and 6
Timeframe: From Baseline to Week 40
Percentage Change in Body Weight between Arms 2, 3 and Arm 6
Timeframe: From Baseline to Week 40
Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5
Timeframe: From Baseline to Week 40
Percentage of Participants Achieving Body Weight Loss
Timeframe: From Baseline to Week 40
Change in Body Weight (kilograms [kg])
Timeframe: From Baseline to Week 40
Change in Body Mass Index (kilograms per square meter [kg/m²])
Timeframe: From Baseline to Week 40
Change in Waist Circumference (centimeter [cm])
Timeframe: From Baseline to Week 40
Change in Hemoglobin A1c (HbA1c) (percentage-points)
Timeframe: From Baseline to Week 40
Change in Fasting Insulin
Timeframe: From Baseline to Week 40
Change in Fasting Glucose
Timeframe: From Baseline to Week 40
Change in Systolic Blood Pressure
Timeframe: From Baseline to Week 40
Change in Diastolic Blood Pressure
Timeframe: From Baseline to Week 40
Change in High-Density Lipoprotein (HDL) Cholesterol
Timeframe: From Baseline to Week 40
Change in Low-Density Lipoprotein (LDL) Cholesterol
Timeframe: From Baseline to Week 40
Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol
Timeframe: From Baseline to Week 40
Change in Non-HDL Cholesterol
Timeframe: From Baseline to Week 40
Change in Total Cholesterol
Timeframe: From Baseline to Week 40
Change in Free Fatty Acids
Timeframe: From Baseline to Week 40
Change in Triglycerides
Timeframe: From Baseline to Week 40
Change in High-Sensitivity C-reactive Protein (hsCRP)
Timeframe: From Baseline to Week 40
Number of Participants with Adverse Events (AEs)
Timeframe: From Baseline to Week 40
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
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
- Related resource (www.gene.com)