The primary objective of this study is to determine the effects of ribupatide administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
264
SC Injection
SC Injection
Percent Change From Baseline in Body Weight at Week 48
Time frame: Baseline, Week 48
Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight
Time frame: Baseline, Week 48
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 48
Change From Baseline in Absolute Body Weight
Time frame: Baseline, Week 48
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Triglycerides
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Total Cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol
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Kailera Clinical Site
Mesa, Arizona, United States
Kailera Clinical Site
Sun City West, Arizona, United States
Kailera Clinical Site
Irvine, California, United States
Kailera Clinical Site
Lake Forest, California, United States
Kailera Clinical Site
Lomita, California, United States
Kailera Clinical Site
Long Beach, California, United States
Kailera Clinical Site
Montclair, California, United States
Kailera Clinical Site
Rolling Hills Estates, California, United States
Kailera Clinical Site
San Diego, California, United States
Kailera Clinical Site
Santa Ana, California, United States
...and 25 more locations
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Insulin
Time frame: Baseline, Week 48
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Week 52
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Day 1 up to Week 52
Number of Participants With Neutralizing Antibodies (NAbs)
Time frame: Day 1 up to Week 52
Plasma Concentrations of Ribupatide
Time frame: Day 1 up to Week 52