A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease
- Summary
- This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and established cardiovascular disease (CVD).
- Acronym
- ZUPREME-5
- Short title
- A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease
- Official title
- A Phase III, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide Vs. Placebo in Participants With Overweight Or Obesity And Established Cardiovascular Disease
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2030-10-06
- First posted
- 2026-09-28
- Registry last updated
- 2026-10-07
- Primary completion date
- 2030-07-28
- Start date
- 2026-09-30
- Participants
- 2,500
- Participant count basis
- Estimated
- Planned participants
- 2,500
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Hoffmann-La Roche
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07843472
- ClinicalTrials.gov ID
- NCT07843472
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Percentage Change in Body Weight from Baseline
Timeframe: From Baseline to Week 64
Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline
Timeframe: From Baseline to Week 64
Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline
Timeframe: From Baseline to Week 64
Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline
Timeframe: From Baseline to Week 64
Change from Baseline in Waist Circumference (cm)
Timeframe: From Baseline to Week 64
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Timeframe: From Baseline to Week 64
Change from Baseline in Triglycerides
Timeframe: From Baseline to Week 64
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol
Timeframe: From Baseline to Week 64
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT) Physical Functioning Composite Score
Timeframe: From Baseline to Week 64
Change from Baseline in IWQoL-Lite-CT Physical Functioning Composite Score in Participants with Poor Physical Functioning at Baseline (as defined by Patient Global Impression of Severity/Status [PGI-S])
Timeframe: From Baseline to Week 64
Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Timeframe: From Baseline to Week 64
Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score in Participants with Poor Physical Functioning at Baseline (as defined by PGI-S)
Timeframe: From Baseline to Week 64
Change from Baseline in Mean Daily Food Craving Score
Timeframe: From Baseline to Week 64
Change from Baseline in Mean Daily Peak Hunger Score
Timeframe: From Baseline to Week 64
Change from Baseline in Body Mass Index (BMI) (kg/m²)
Timeframe: From Baseline to Week 64
Change from Baseline in Body Weight (kg)
Timeframe: From Baseline to Week 64
Change from Baseline in Waist-to-Hip Ratio
Timeframe: From Baseline to Week 64
Change from Baseline in Waist-to-Height Ratio
Timeframe: From Baseline to Week 64
Change from Baseline in Fasting Insulin
Timeframe: From Baseline to Week 64
Change from Baseline in Fasting Glucose
Timeframe: From Baseline to Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Timeframe: From Baseline to Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 5.7%
Timeframe: At Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 6.5%
Timeframe: At Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 7%
Timeframe: At Week 64
Percentage of Participants With Baseline Prediabetes Achieving HbA1c of < 5.7%
Timeframe: At Week 64
Change from Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol
Timeframe: From Baseline to Week 64
And 17 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 40 Years
- Healthy volunteers
- No
- Participants with BMI ≥ 27 kg/m² and established CVD
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Known history of Type 1 diabetes mellitus
- Current or previous treatment with petrelintide or any other amylin analog
- Pinnacle Research GroupAnniston, United StatesRecruiting
- Institute for Metabolic Research Los AngelesLos Angeles, United StatesRecruiting
- Progressive Medical ResearchPort Orange, United StatesRecruiting
Other registry identifiers
- 2026-526190-41-00
Related records
Drugs (1)
Collaborators (1)
Lead sponsors (1)
Conditions (2)
- Cardiovascular disorder
- Obesity disorder Primary condition