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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07656727). StuddyBuddy aggregates publicly available trial information.