A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease
ZUPREME-5
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
2 other identifiers
interventional
2,500
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2026
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2026
CompletedFirst Posted
Study publicly available on registry
September 28, 2026
CompletedStudy Start
First participant enrolled
September 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 6, 2030
September 28, 2026
September 1, 2026
3.8 years
September 22, 2026
September 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage Change in Body Weight from Baseline
From Baseline to Week 64
Secondary Outcomes (42)
Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline
From Baseline to Week 64
Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline
From Baseline to Week 64
Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline
From Baseline to Week 64
Change from Baseline in Waist Circumference (cm)
From Baseline to Week 64
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
From Baseline to Week 64
- +37 more secondary outcomes
Study Arms (2)
Petrelintide
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Petrelintide will be administered subcutaneously (SC) using a drug-device combination product.
Petrelintide-matching placebo will be administered SC using a drug-device combination product.
Eligibility Criteria
You may qualify if:
- Participants with BMI ≥ 27 kg/m² and established CVD
- History of at least one self-reported unsuccessful dietary effort to lose body weight
You may not qualify if:
- Known history of Type 1 diabetes mellitus
- Current or previous treatment with petrelintide or any other amylin analog
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Zealand Pharmacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Reference Study ID Number: CC46446 https://forpatients.roche.com/No attachments to email below.
CONTACT
Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2026
First Posted
September 28, 2026
Study Start
September 30, 2026
Primary Completion (Estimated)
July 28, 2030
Study Completion (Estimated)
October 6, 2030
Last Updated
September 28, 2026
Record last verified: 2026-09