Study of Oral BGE-102 Capsules to Assess Inflammation, Safety, and Tolerability in Adults with Obesity and Cardiovascular Risk

What this Trial Is About

This research aims to evaluate the effects of BGE-102 on blood biomarkers related to inflammation, such as hsCRP, in adults with obesity and cardiovascular risk factors. The study focuses on understanding the safety, tolerability, and pharmacodynamics of BGE-102. It involves participants who are obese with elevated inflammation markers and at least one cardiovascular or metabolic risk factor. Participants will be randomly assigned to receive one of three doses of BGE-102 or a matching placebo. The study drug is taken orally once daily in the morning for 12 weeks. The total study duration is about 20 weeks, including 4 weeks of screening, 12 weeks of treatment, and 4 weeks of post-treatment follow-up. Visits occur every 2 weeks during the first 4 weeks of treatment and every 4 weeks thereafter until week 16. Throughout the study, participants will undergo assessments to monitor inflammation levels, safety, and tolerability. Researchers will measure changes in hsCRP as a primary outcome and track any adverse events. Participants will have regular visits for lab tests, vital signs, and questionnaires. The study also includes follow-up after treatment to monitor ongoing safety and effects, with total participation lasting approximately 5 months.

A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors