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

A Phase 2, Randomized, Double-Blind, Dose-Range, Placebo-Controlled, 12-Week Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors

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.

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.

Key Inclusion Criteria:

• Obese Male and Female adults with BMI 32-42 kg/m²
• Elevated blood test for hsCRP consistent with chronic systemic inflammation
• At least one cardiovascular risk factor or metabolic syndrome feature
• Stable background therapies and willing to maintain stable diet/exercise habits during the study

Key Exclusion Criteria:

• Type 1 diabetes,
• Uncontrolled Type 2 diabetes,
• Uncontrolled hypertension and /or hyperlipidemia
• Recent weight change of 5% or more,
• Use of weight-loss medications/programs
• Clinically relevant medical condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
• Clinically significant ECG abnormalities or arrhythmias
• Use of prohibited medications (including GLP-1 therapies, immunosuppressants, chronic anti-inflammatory drugs, or moderate or strong CYP3A4 modulators)
• Contraindications to MRI
• Clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or take drugs that directly affect GI motility, have undergone prior surgical treatment for obesity (e.g., gastric bypass [bariatric] surgery or restrictive bariatric surgery), or have an endoscopic and/or device-based therapy for obesity
• Women who are pregnant or nursing