The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,200
Percent Change From Baseline in Body Weight at Week 76
Time frame: Baseline, Week 76
Percentage of Participants with ≥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
Percentage of Participants with ≥5% Reduction in 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
Percentage of Participants with ≥30% Reduction in Body Weight
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kailera Clinical Site
Glendale, Arizona, United States
RECRUITINGKailera Clinical Site
Phoenix, Arizona, United States
RECRUITINGKailera Clinical Site
Little Rock, Arkansas, United States
RECRUITINGKailera Clinical Site
Northridge, California, United States
RECRUITINGKailera Clinical Site
Oceanside, California, United States
RECRUITINGKailera Clinical Site
Hamden, Connecticut, United States
RECRUITINGKailera Clinical Site
Stamford, Connecticut, United States
RECRUITINGKailera Clinical Site
Orange City, Florida, United States
RECRUITINGKailera Clinical Site
Albany, Georgia, United States
RECRUITINGKailera Clinical Site
Chicago, Illinois, United States
RECRUITING...and 49 more locations
Time frame: Baseline, Week 76
Change From Baseline in Body Mass Index (BMI)
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