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

简要总结

主要结局

次要结局

• Change from Baseline in Waist-to-Hip Ratio(From Baseline to Week 64)
• Change from Baseline in Triglycerides(From Baseline to Week 64)
• Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol(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(From Baseline to Week 64)
• 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)
• 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])(From Baseline to Week 64)
• Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score(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)(From Baseline to Week 64)
• Change from Baseline in Mean Daily Food Craving Score(From Baseline to Week 64)
• Change from Baseline in Mean Daily Peak Hunger Score(From Baseline to Week 64)
• Change from Baseline in Body Mass Index (BMI) (kg/m²)(From Baseline to Week 64)
• Change from Baseline in Body Weight (kg)(From Baseline to Week 64)
• Change from Baseline in Waist-to-Height Ratio(From Baseline to Week 64)
• Change from Baseline in Fasting Insulin(From Baseline to Week 64)
• Change from Baseline in Fasting Glucose(From Baseline to Week 64)
• Change from Baseline in Hemoglobin A1c (HbA1c)(From Baseline to Week 64)
• Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 5.7%(At Week 64)
• Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 6.5%(At Week 64)
• Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 7%(At Week 64)
• Percentage of Participants With Baseline Prediabetes Achieving HbA1c of < 5.7%(At Week 64)
• Change from Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol(From Baseline to Week 64)
• Change from Baseline in Non-HDL Cholesterol(From Baseline to Week 64)
• Change from Baseline in Total Cholesterol(From Baseline to Week 64)
• Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol(From Baseline to Week 64)
• Change from Baseline in Free Fatty Acids(From Baseline to Week 64)
• Change from Baseline in Systolic Blood Pressure(From Baseline to Week 64)
• Change from Baseline in Diastolic Blood Pressure(From Baseline to Week 64)
• Change from Baseline in Health-Related Quality of Life (HRQoL) as assessed by SF-36v2 Acute Form Domain Scores and Component Summary Scores(From Baseline to Week 64)
• Change from Baseline in HRQoL as assessed by IWQoL-Lite-CT Domain Scores and Total Score(From Baseline to Week 64)
• Proportion of Participants with ≥ 14.6-Point Increase from Baseline in IWQoL-Lite-CT Physical Function Score(From Baseline to Week 64)
• Proportion of Participants with ≥ 3.7-Point Increase from Baseline in SF36v2 Physical Functioning Score(From Baseline to Week 64)
• Proportion of Participants with Baseline Poor Physical Functioning Achieving ≥ 14.6-Point Increase in IWQoL-Lite-CT Physical Functioning Score(From Baseline to Week 64)
• Proportion of Participants with Baseline Poor Physical Functioning Achieving a ≥ 3.7-Point Increase in SF36v2 Physical Functioning Score(From Baseline to Week 64)
• Change from Baseline in Mean Daily Average Hunger Score(From Baseline to Week 64)
• Change from Baseline in Mean Daily Average Satiety Score(From Baseline to Week 64)
• Change from Baseline in Mean Daily Average Appetite Score(From Baseline to Week 64)
• Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria(From Baseline to Week 64)
• Percentage of Participants with Baseline Anti-Drug Antibodies (ADAs) and Treatment-Emergent ADAs Against Petrelintide(From Baseline to Week 64)