The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,340
SC Injection
SC Injection
Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame: Baseline, Week 76
Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame: Baseline, Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Time frame: Baseline, Week 76
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 76
Change From Baseline in Absolute Body Weight
Time frame: Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time frame: Baseline, Week 76
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time frame: Baseline, Week 76
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
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Kailera Clinical Site
Anniston, Alabama, United States
RECRUITINGKailera Clinical Site
Birmingham, Alabama, United States
RECRUITINGKailera Clinical Site
Cullman, Alabama, United States
RECRUITINGKailera Clinical Site
Sun City, Arizona, United States
RECRUITINGKailera Clinical Site
Escondido, California, United States
RECRUITINGKailera Clinical Site
Toluca Lake, California, United States
RECRUITINGKailera Clinical Site
Aurora, Colorado, United States
RECRUITINGKailera Clinical Site
Bridgeport, Connecticut, United States
RECRUITINGKailera Clinical Site
Jupiter, Florida, United States
RECRUITINGKailera Clinical Site
Lilburn, Georgia, United States
RECRUITING...and 94 more locations
Time frame: Baseline, Week 76
Percentage of Participants with ≥30% Reduction in Body Weight
Time frame: Baseline, Week 76
Change From Baseline in BMI
Time frame: Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 76
Percent Change From Baseline in Total Cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Low-density Lipoprotein (LDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
Time frame: Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Time frame: Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Time frame: Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Time frame: Up to Week 80
Plasma Concentrations of Ribupatide
Time frame: Up to Week 76