A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living with Obesity Who Do Not Have Diabetes

Conditions

Obesity

Brief summary

Percent change in body weight (kg) from baseline at Week 76

Detailed description

controlled for Type I error 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), controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5% reduction in body weight (kg) Change in - SBP − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change in WQOL-LiteCT Physical function composite score, 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) • Change in: − CoEQ Craving Control score − Positive Mood score − Craving for Sweets score − Craving for Savory food score − Hunger score − Satiety score − Combined score • Change in FNQ score, not controlled for Type I error Number ofTEAEs, not controlled for Type I error ADA NAb, not controlled for Type I error Concentrations of KAI-9531

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGWegovy 0.25 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 0.5 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 1.7 mg FlexTouch solution for injection in pre-filled pen

DRUGWegovy 2.4 mg FlexTouch solution for injection in pre-filled pen

DRUGKAI-9531

DRUGWegovy 1 mg FlexTouch solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change in body weight (kg) from baseline at Week 76	—

Secondary

Measure	Time frame
controlled for Type I error 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), controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5% reduction in body weight (kg) Change in - SBP − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change in WQOL-LiteCT Physical function composite score, 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) • Change in: − CoEQ Craving Control score − Positive Mood score − Craving for Sweets score − Craving for Savory food score − Hunger score − Satiety score − Combined score • Change in FNQ score, not controlled for Type I error Number ofTEAEs, not controlled for Type I error ADA NAb, not controlled for Type I error Concentrations of KAI-9531	—

Measure

Time frame

controlled for Type I error 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), controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5% reduction in body weight (kg) Change in - SBP − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change in WQOL-LiteCT Physical function composite score, 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) • Change in: − CoEQ Craving Control score − Positive Mood score − Craving for Sweets score − Craving for Savory food score − Hunger score − Satiety score − Combined score • Change in FNQ score, not controlled for Type I error Number ofTEAEs, not controlled for Type I error ADA NAb, not controlled for Type I error Concentrations of KAI-9531

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Outcome results

None listed