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NCT07656727
A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors
Conditions: Obesity and Cardiovascular Risk
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 160
Sponsor: BioAge Labs, Inc.
Location: Site 108 Chandler Arizona
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 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
Source: ClinicalTrials.gov (NCT07656727). StuddyBuddy aggregates publicly available trial information.