The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Time frame: Baseline, Week 44
Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Time frame: Baseline, Week 44
Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus
Time frame: Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus
Time frame: Week 44
Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time frame: Baseline, Week 44
Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time frame: Baseline, Week 44
Change from Baseline in BMI at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time frame: Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Living with Type 2 Diabetes Mellitus
Time frame: Week 44
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