The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
150
Administered SC.
Administered SC.
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit
Dallas, Texas, United States
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, United States
Percent Change in Body Weight
Time frame: Week 1, Week 29
Number of Participants who discontinued due to an Adverse Events (AEs)
Time frame: Day 1 through Week 37
Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs
Time frame: Day 1 through Week 37
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide
Time frame: Pre-dose on Day 1 through Week 37
PK: Maximum Concentration (Cmax) of Brenipatide
Time frame: Pre-dose on Day 1 through Week 37
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight
Time frame: Week 29
Change in Waist Circumference
Time frame: Week 1, Week 29
Change in Waist-to-Height Ratio
Time frame: Week 1, Week 29
Change in Blood Pressure
Time frame: Week 1, Week 29
Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C)
Time frame: Week 1, Week 29
Change in High-sensitive C-reactive Protein (hsCRP)
Time frame: Week 1, Week 29
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