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

June 15, 2026 updated by: BioAge Labs, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Peoria, Arizona, United States, 85381
      • Tucson, Arizona, United States, 85711
    • Arkansas
      • Rogers, Arkansas, United States, 72758
    • Florida
      • Maitland, Florida, United States, 32751
      • Miami, Florida, United States, 33172
      • Port Orange, Florida, United States, 32127
    • Kentucky
      • Lexington, Kentucky, United States, 40509
    • Maryland
      • Rockville, Maryland, United States, 20854
    • Missouri
      • Kansas City, Missouri, United States, 64131
    • Texas
      • Austin, Texas, United States, 78759
      • San Antonio, Texas, United States, 78240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: BGE-102 Dose A
capsules dosed once daily in the morning
Drug: Oral BGE-102
Capsules
Experimental: Arm B: BGE-102 Dose B
capsules dosed once daily in the morning
Drug: Oral BGE-102
Capsules
Experimental: Arm C: BGE-102 Dose C
capsules dosed once daily in the morning
Drug: Oral BGE-102
Capsules
Placebo Comparator: Arm D: Dose D
capsules dosed once daily in the morning
Drug: Oral Placebo Matching BGE-102
Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in hsCRP (Dose A)
Time Frame: Week 12
Percent change in hsCRP of the BGE-102 Dose A daily compared to Placebo
Week 12
Percent change in hsCRP (Dose B)
Time Frame: Week 12
Percent change in hsCRP of the BGE-102 Dose B daily compared to Placebo
Week 12
Percent change in hsCRP (Dose C)
Time Frame: Week 12
Percent change in hsCRP of the BGE-102 Dose C daily compared to Placebo
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse events (SAEs)
Time Frame: Up to Week 16
Up to Week 16
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to Week 16
Up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAge Labs, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGE-102-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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