A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors
Start Date
6/11/2026
Completion Date
12/1/2026
Summary
The purpose of this study is to learn about the effects of BGE-102 on blood biomarkers including hsCRP, which is a lab value used to measure inflammation. BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo. This study will be checking safety and tolerability of BGE-102.
Detailed Description
The purpose of this study is to assess the pharmacodynamics and safety of oral once a day (QD) dosing of BGE-102 at 3 dose levels compared to placebo over 12 weeks of treatment. Study details include: * The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks). * The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16. * The treatment duration will be up to 12 weeks. BGE-102 will be given as Dose A, Dose B or Dose C QD capsules or placebo QD capsules for the entire 12-week treatment period.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Oral BGE-102
Oral Placebo Matching BGE-102
Conditions
Locations
Site 108
Chandler, Arizona 85225
United States
Site 115
Peoria, Arizona 85381
United States
Site 110
Tucson, Arizona 85711
United States
Site 100
Rogers, Arkansas 72758
United States
Site 109
Maitland, Florida 32751
United States
Site 102
Miami, Florida 33172
United States
Site 104
Port Orange, Florida 32127
United States
Site 103
Lexington, Kentucky 40509
United States
Site 106
Rockville, Maryland 20854
United States
Site 113
Kansas City, Missouri 64131
United States
Site 112
Austin, Texas 78759
United States
Site 101
San Antonio, Texas 78240
United States
Site 105
San Juan, 00927
Puerto Rico