Obesity
Conditions
Brief summary
Percent change in body weight (kg) from baseline at Week 76
Detailed description
Percent change in body weight (kg) from baseline at Week 76, 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 body weight (kg) Change (all KAI-9531 doses combined) in SBP (mm Hg) Percent change (all KAI-9531 doses combined) in (fasting): − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change (all KAI-9531 doses combined) in IWQOL-Lite-CT physical function composite score, Percent change in body weight (kg) from baseline at Week 76 in the subgroup of participants with BMI ≥35 kg/m2, From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight(kg).Change in BMI(kg/m2).Change(all KAI-9531 doses combined) in DBP (mm Hg).Percent change(all KAI-9531 doses combined) in(fasting):−Total cholesterol(mg/dL)−LDL-cholesterol(mg/dL)−VLDL-cholesterol(mg/dL). Percent change(all KAI-9531 doses combined) in fasting insulin (mIU/L).Change(all KAI-9531 doses combined) in fasting blood glucose (mg/dL).Change(all KAI-9531 doses combined) in COEQ, TEAEs, clinical laboratory parameters, ECGs, and vital sign, ADA NAb, Population PK Efficacy, safety, and tolerability exposure-response analysis
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight (kg) from baseline at Week 76 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in body weight (kg) from baseline at Week 76, 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 body weight (kg) Change (all KAI-9531 doses combined) in SBP (mm Hg) Percent change (all KAI-9531 doses combined) in (fasting): − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change (all KAI-9531 doses combined) in IWQOL-Lite-CT physical function composite score, Percent change in body weight (kg) from baseline at Week 76 in the subgroup of participants with BMI ≥35 kg/m2, From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight(kg).Change in BMI(kg/m2).Change(all KAI-9531 doses combined) in DBP (mm Hg).Percent change(all KAI-9531 doses combined) in(fasting):−Total cholesterol(mg/dL)−LDL-cholesterol(mg/dL)−VLDL-cholesterol(mg/dL). Percent change(all KAI-9531 doses combined) in fasting insulin ( | — |