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

NCT07656727

Active Not RecruitingPhase 2

Sponsor: BioAge Labs, Inc.

Conditions: Obesity and Cardiovascular Risk

Interventions: Oral BGE-102, Oral Placebo Matching BGE-102

Countries: United States, Puerto Rico

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (17)
  • Chandler, Arizona, United States
  • Peoria, Arizona, United States
  • Tucson, Arizona, United States
  • Rogers, Arkansas, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Port Orange, Florida, United States
  • Lexington, Kentucky, United States
  • Rockville, Maryland, United States
  • Kansas City, Missouri, United States
  • Las Vegas, Nevada, United States
  • Hartsdale, New York, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Sugar Land, Texas, United States
  • San Juan, Puerto Rico