A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease

Browse trials for

• Obesity 6,258
• Overweight 3,656
• Cardiovascular Diseases 4,895

Study arms

• Experimental
  Petrelintide

  Combination Product: Petrelintide

• Placebo comparator
  Placebo

  Combination Product: Placebo

Interventions

• Combination productPetrelintide

  Petrelintide will be administered subcutaneously (SC) using a drug-device combination product.

  Also known as: RO7895515, ZP8396

• Combination productPlacebo

  Petrelintide-matching placebo will be administered SC using a drug-device combination product.

Primary outcomes

1. Percentage Change in Body Weight from Baseline

   Time frame: From Baseline to Week 64

Secondary outcomes

1. Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline

   Time frame: From Baseline to Week 64

2. Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline

   Time frame: From Baseline to Week 64

3. Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline

   Time frame: From Baseline to Week 64

4. Change from Baseline in Waist Circumference (cm)

   Time frame: From Baseline to Week 64

5. Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

   Time frame: From Baseline to Week 64

6. Change from Baseline in Triglycerides

   Time frame: From Baseline to Week 64

7. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol

   Time frame: 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

   Time frame: 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])

   Time frame: 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

    Time frame: 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)

    Time frame: From Baseline to Week 64

12. Change from Baseline in Mean Daily Food Craving Score

    Time frame: From Baseline to Week 64

13. Change from Baseline in Mean Daily Peak Hunger Score

    Time frame: From Baseline to Week 64

14. Change from Baseline in Body Mass Index (BMI) (kg/m²)

    Time frame: From Baseline to Week 64

15. Change from Baseline in Body Weight (kg)

    Time frame: From Baseline to Week 64

16. Change from Baseline in Waist-to-Hip Ratio

    Time frame: From Baseline to Week 64

17. Change from Baseline in Waist-to-Height Ratio

    Time frame: From Baseline to Week 64

18. Change from Baseline in Fasting Insulin

    Time frame: From Baseline to Week 64

19. Change from Baseline in Fasting Glucose

    Time frame: From Baseline to Week 64

20. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: From Baseline to Week 64

21. Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 5.7%

    Time frame: At Week 64

22. Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 6.5%

    Time frame: At Week 64

23. Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 7%

    Time frame: At Week 64

24. Percentage of Participants With Baseline Prediabetes Achieving HbA1c of < 5.7%

    Time frame: At Week 64

25. Change from Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol

    Time frame: From Baseline to Week 64

26. Change from Baseline in Non-HDL Cholesterol

    Time frame: From Baseline to Week 64

27. Change from Baseline in Total Cholesterol

    Time frame: From Baseline to Week 64

28. Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol

    Time frame: From Baseline to Week 64

29. Change from Baseline in Free Fatty Acids

    Time frame: From Baseline to Week 64

30. Change from Baseline in Systolic Blood Pressure

    Time frame: From Baseline to Week 64

31. Change from Baseline in Diastolic Blood Pressure

    Time frame: From Baseline to Week 64

32. Change from Baseline in Health-Related Quality of Life (HRQoL) as assessed by SF-36v2 Acute Form Domain Scores and Component Summary Scores

    Time frame: From Baseline to Week 64

33. Change from Baseline in HRQoL as assessed by IWQoL-Lite-CT Domain Scores and Total Score

    Time frame: From Baseline to Week 64

34. Proportion of Participants with ≥ 14.6-Point Increase from Baseline in IWQoL-Lite-CT Physical Function Score

    Time frame: From Baseline to Week 64

35. Proportion of Participants with ≥ 3.7-Point Increase from Baseline in SF36v2 Physical Functioning Score

    Time frame: From Baseline to Week 64

36. Proportion of Participants with Baseline Poor Physical Functioning Achieving ≥ 14.6-Point Increase in IWQoL-Lite-CT Physical Functioning Score

    Time frame: From Baseline to Week 64

37. Proportion of Participants with Baseline Poor Physical Functioning Achieving a ≥ 3.7-Point Increase in SF36v2 Physical Functioning Score

    Time frame: From Baseline to Week 64

38. Change from Baseline in Mean Daily Average Hunger Score

    Time frame: From Baseline to Week 64

39. Change from Baseline in Mean Daily Average Satiety Score

    Time frame: From Baseline to Week 64

40. Change from Baseline in Mean Daily Average Appetite Score

    Time frame: From Baseline to Week 64

41. Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria

    Time frame: From Baseline to Week 64

42. Percentage of Participants with Baseline Anti-Drug Antibodies (ADAs) and Treatment-Emergent ADAs Against Petrelintide

    Time frame: From Baseline to Week 64