> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-9b7405fc-7d5b-4282-9068-f7a7ae75be68 > Record changed: 2026-11-04 # A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity NCT07843498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) Participants 3,900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) Start date 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Title and summary **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, at least one weight-related comorbidity, and without Type 2 Diabetes (T2D). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Acronym** ZUPREME-3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Short title** A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Dates **Completion date** 2029-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **First posted** 2026-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Registry last updated** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Primary completion date** 2028-12-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Start date** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Size and sites **Participants** 3,900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Planned participants** 3,900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Identifiers **Registry ID** NCT07843498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **ClinicalTrials.gov ID** NCT07843498 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Outcomes ### Primary outcomes 1. Percentage Change in Body Weight from Baseline Timeframe: From Baseline to Week 64 ### Secondary outcomes 1. Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline Timeframe: From Baseline to Week 64 2. Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline Timeframe: From Baseline to Week 64 3. Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline Timeframe: From Baseline to Week 64 4. Change from Baseline in Waist Circumference (cm) Timeframe: From Baseline to Week 64 5. Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Timeframe: From Baseline to Week 64 6. Change from Baseline in Triglycerides Timeframe: From Baseline to Week 64 7. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol Timeframe: From Baseline to Week 64 8. 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 9. 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 10. 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 11. 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 12. Change from Baseline in Mean Daily Food Craving Score Timeframe: From Baseline to Week 64 13. Change from Baseline in Mean Daily Peak Hunger Score Timeframe: From Baseline to Week 64 14. Change from Baseline in Body Mass Index (BMI) (kg/m²) Timeframe: From Baseline to Week 64 15. Change from Baseline in Body Weight (kg) Timeframe: From Baseline to Week 64 16. Change from Baseline in Waist-to-Hip Ratio Timeframe: From Baseline to Week 64 17. Change from Baseline in Waist-to-Height Ratio Timeframe: From Baseline to Week 64 18. Change from Baseline in Fasting Insulin Timeframe: From Baseline to Week 64 19. Change from Baseline in Fasting Glucose Timeframe: From Baseline to Week 64 20. Change from Baseline in Hemoglobin A1c (HbA1c) Timeframe: From Baseline to Week 64 21. Percentage of Participants Achieving HbA1c of <5.7% Timeframe: At Week 64 22. Change from Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol Timeframe: From Baseline to Week 64 23. Change from Baseline in Non-HDL Cholesterol Timeframe: From Baseline to Week 64 24. Change from Baseline in Total Cholesterol Timeframe: From Baseline to Week 64 25. Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol Timeframe: From Baseline to Week 64 And 16 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants with BMI ≥ 30 kg/m² or BMI ≥ 27 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%), measured by the central laboratory at screening - Known history of Type 1 or Type 2 diabetes mellitus - Current or previous treatment with petrelintide or any other amylin analog Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Sites - Pinnacle Research GroupAnniston, United StatesRecruiting - Progressive Medical ResearchPort Orange, United StatesRecruiting - Clinical Research AssociatesNashville, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## References ### Other registry identifiers - 2026-526188-39-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07843498) ## Related records ### Drugs (1) - [Petrelintide](https://trialight.com/data/asset/petrelintide-b3738a49-6b24-44d3-b78a-1cda49db7323.md) ### Collaborators (1) - [Zealand Pharma](https://trialight.com/data/company/zealand-pharma-95a70d21-85c7-458e-ac9a-895e39993340.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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