A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight and Diabetes

Obesity

Percent change in body weight (kg) from baseline at Week 76. Change in hemoglobin A1c (%) from baseline at Week 76

Controlled for Type I error Percent change in body weight (kg) from baseline at Week 76, Controlled for Type I error Change in hemoglobin A1c (%) from baseline at Week 76, Percentage of participants with ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) • Change in waist circumference (cm) • Change in absolute weight (kg) • Percentage of participants with HbA1c <7% and ≤6.5% • Change in fasting blood glucose (mg/dL • Change in SBP (mm Hg) • Percent change in fasting: − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) • Change in IWQOL-Lite-CT physical function composite score, Controlled for Type I error: Percent change in body weight (kg) from baseline at Week 76 in subgroup of participants with BMI ≥35 kg/m2, Not controlled for Type I error:From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight (kg).Change in BMI (kg/m2).Percentage of participants with HbA1c <5.7%.Change in DBP (mm Hg).Percent change in fasting:Total cholesterol (mg/dL)−LDL-cholesterol (mg/dL)−VLDL-cholesterol (mg/dL)−insulin (mIU/L).Change in Control of Eating Questionnaire (COEQ).Change (all KAI-9531 doses combined) in Food Noise Questionnaire (FNQ) score, Not controlled for Type I error: • Treatment-emergent adverse events (TEAEs), Not controlled for Type I error: • Antidrug antibodies (ADAs) • Neutralizing antibodies (NAbs), Not controlled for Type I error: Concentrations of KAI-9531

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