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NCT07656727PHASE2Recruiting

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

BioAge Labs, Inc.

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

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

Interventions

DRUG

Oral BGE-102

DRUG

Oral Placebo Matching BGE-102

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Conditions

Obesity and Cardiovascular Risk

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