Recruiting

Phase 2

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

Sponsor:

BioAge Labs, Inc.

Code:

NCT07656727

Conditions

Obesity and Cardiovascular Risk

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral BGE-102

Oral Placebo Matching BGE-102

Study Details

Brief 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.

Conditions

Obesity and Cardiovascular Risk

Study ID

NCT07656727

Start date

Jun 11, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: BGE-102 Dose A

capsules dosed once daily in the morning

experimental: Arm B: BGE-102 Dose B

capsules dosed once daily in the morning

experimental: Arm C: BGE-102 Dose C

capsules dosed once daily in the morning

placebo comparator: Arm D: Dose D

capsules dosed once daily in the morning

Interventions

Oral BGE-102

Capsules

Oral Placebo Matching BGE-102

Capsules

Primary outcome measure

Percent change in hsCRP (Dose A) [ Time Frame: Week 12 ]
Percent change in hsCRP (Dose B) [ Time Frame: Week 12 ]
Percent change in hsCRP (Dose C) [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Locations

Site 108

Recruiting

Chandler, Arizona, United States, 85225

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 115

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 110

Recruiting

Tucson, Arizona, United States, 85711

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 100

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 109

Recruiting

Maitland, Florida, United States, 32751

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 102

Recruiting

Miami, Florida, United States, 33172

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 104

Recruiting

Port Orange, Florida, United States, 32127

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 106

Recruiting

Rockville, Maryland, United States, 20854

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 113

Recruiting

Kansas City, Missouri, United States, 64131

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 112

Recruiting

Austin, Texas, United States, 78759

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

Site 101

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Central Recruiting

866-521-2210 infobge102-005@bioagelabs.com

More Information

Sponsor

BioAge Labs, Inc.

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

Obesity
Cardiovascular
BGE-102
hsCRP
BioAge
NLRP3

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BioAge Labs, Inc. on 2026-06-18.