RecruitingPhase 2NCT07656727

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


Sponsor

BioAge Labs, Inc.

Enrollment

160 participants

Start Date

Jun 11, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria11

  • 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

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Interventions

DRUGOral BGE-102

Capsules

DRUGOral Placebo Matching BGE-102

Capsules


Locations(13)

Site 108

Chandler, Arizona, United States

Site 115

Peoria, Arizona, United States

Site 110

Tucson, Arizona, United States

Site 100

Rogers, Arkansas, United States

Site 109

Maitland, Florida, United States

Site 102

Miami, Florida, United States

Site 104

Port Orange, Florida, United States

Site 103

Lexington, Kentucky, United States

Site 106

Rockville, Maryland, United States

Site 113

Kansas City, Missouri, United States

Site 112

Austin, Texas, United States

Site 101

San Antonio, Texas, United States

Site 105

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT07656727


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