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

NCT07656727 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BGE-102-005
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 13

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

Keywords

Obesity; Cardiovascular; BGE-102; hsCRP; BioAge; NLRP3

Outcome Measures

Primary Outcomes (3)

• Percent change in hsCRP (Dose A)

  Percent change in hsCRP of the BGE-102 Dose A daily compared to Placebo

  Week 12

• Percent change in hsCRP (Dose B)

  Percent change in hsCRP of the BGE-102 Dose B daily compared to Placebo

  Week 12

• Percent change in hsCRP (Dose C)

  Percent change in hsCRP of the BGE-102 Dose C daily compared to Placebo

  Week 12

Secondary Outcomes (2)

• Incidence of serious adverse events (SAEs)

  Up to Week 16

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to Week 16

Study Arms (4)

Arm A: BGE-102 Dose A

EXPERIMENTAL

capsules dosed once daily in the morning

Drug: Oral BGE-102

Arm B: BGE-102 Dose B

EXPERIMENTAL

capsules dosed once daily in the morning

Drug: Oral BGE-102

Arm C: BGE-102 Dose C

EXPERIMENTAL

capsules dosed once daily in the morning

Drug: Oral BGE-102

Arm D: Dose D

PLACEBO COMPARATOR

capsules dosed once daily in the morning

Drug: Oral Placebo Matching BGE-102

Interventions

Oral BGE-102 DRUG

Capsules

Arm A: BGE-102 Dose A; Arm B: BGE-102 Dose B; Arm C: BGE-102 Dose C

Oral Placebo Matching BGE-102 DRUG

Capsules

Arm D: Dose D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioAge Labs, Inc.: lead

Study Sites (13)

Site 108

Chandler, Arizona, 85225, United States

RECRUITING

Site 115

Peoria, Arizona, 85381, United States

RECRUITING

Site 110

Tucson, Arizona, 85711, United States

RECRUITING

Site 100

Rogers, Arkansas, 72758, United States

RECRUITING

Site 109

Maitland, Florida, 32751, United States

RECRUITING

Site 102

Miami, Florida, 33172, United States

RECRUITING

Site 104

Port Orange, Florida, 32127, United States

RECRUITING

Site 103

Lexington, Kentucky, 40509, United States

NOT YET RECRUITING

Site 106

Rockville, Maryland, 20854, United States

RECRUITING

Site 113

Kansas City, Missouri, 64131, United States

RECRUITING

Site 112

Austin, Texas, 78759, United States

RECRUITING

Site 101

San Antonio, Texas, 78240, United States

RECRUITING

Site 105

San Juan, 00927, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Central Recruiting

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); PR (1)