A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

简要总结

主要结局

次要结局

• Achieve ≥5% body weight loss at Week 72 (Yes/No)
• Achieve ≥10% body weight loss at Week 72 (Yes/No)
• Achieve ≥15% body weight loss at Week 72 (Yes/No)
• Change from baseline in body weight (kg) at Week 72
• Change from baseline in HbA1c at Week 72
• Achieve HbA1c of ≤ 6.5% at Week 72 (Yes/No)
• Achieve HbA1c of <7% at Week 72 (Yes/No)
• Change from baseline in waist circumference (cm) at Week 72
• Change from baseline in fasting glucose at Week 72
• Change from baseline in fasting insulin at Week 72
• Change from baseline in LDL cholesterol at Week 72
• Change from baseline in HDL cholesterol at Week 72
• Change from baseline in triglyceride at Week 72
• Change from baseline in systolic blood pressure at Week 72
• Change from baseline in physical functioning as assessed by physical functioning domain of Short Form (36) Health Survey Version 2 Acute Form (SF-36v2 Acute Form) at Week 72
• Change from baseline in physical functioning composite as assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) at Week 72
• Change from baseline in waist-to-hip ratio at Week 72
• Change from baseline in waist-to-height ratio at Week 72
• Change from baseline in Control of Eating Questionnaire (CoEQ) subscale scores for craving control, positive mood, craving for savory and craving for sweet; and the individual hunger item score at Week 72
• Change from baseline on symptoms and impact of urinary incontinence as assessed by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at Week 72
• Experience no change, improvement, or worsening in Patient Global Impression of Change (PGI-C) Urinary Incontinence at Week 72
• Experience no change, improvement, or worsening in Patient Global Impression of Severity/Status (PGI-S) Urinary Incontinence at Week 72
• Experience no change, improvement, or worsening in PGI-C Physical Functioning at Week 72
• Experience no change, improvement, or worsening in PGI-S Physical Functioning at Week 72
• Change from baseline in HRQoL as assessed by SF-36v2 Acute Form domain scores and component summary scores at Week 72
• Change from baseline in HRQoL as assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) domain scores and total score at Week 72
• Change from baseline at Week 72 in non-HDL cholesterol
• Change from baseline at Week 72 in VLDL cholesterol
• Change from baseline at Week 72 in total cholesterol
• Change from baseline at Week 72 in free fatty acids
• Change from baseline at Week 72 in diastolic blood pressure
• Change from baseline at Week 72 in high-sensitivity C-reactive protein (hsCRP)
• Change from baseline in urinary albumin/creatinine ratio at Week 72
• Achieve ≥ 15% body weight loss at Week 72 (Yes/No)
• Change from baseline in BMI at Week 72
• Percent change from baseline in weight by obesity class, at Week 72
• Time to achieve ≥5%, ≥10% and ≥15% weight loss from baseline through Week 72 (weeks)
• Achieve HbA1c of < 5.7% at Week 72 (Yes/No)
• Incidence and severity of adverse events (AEs) (including SAEs, AESIs and AEs leading to study drug discontinuation), with severity determined according to mild/moderate/severe criteria
• Change from baseline in selected safety laboratory values, vital signs, and ECGs through Week 72
• Changes from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire-9 (PHQ-9) through Week 72