Clinical trial

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

Recruiting now · Phase 2 · 2 countries · Registry ID NCT07656727

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity and Cardiovascular Risk

Full registry 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

Treatments and study arms

Oral BGE-102

Drug

Capsules

Oral Placebo Matching BGE-102

Drug

Capsules

Primary outcomes

Percent change in hsCRP (Dose A)Week 12

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

Percent change in hsCRP (Dose B)Week 12

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

Percent change in hsCRP (Dose C)Week 12

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

Study locations

13 locations were listed when this page was built. The first 40 are shown.

Site 105🇵🇷 San Juan, Puerto Rico
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Site 112🇺🇸 Austin, Texas, United States
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Site 108🇺🇸 Chandler, Arizona, United States
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Site 113🇺🇸 Kansas City, Missouri, United States
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Site 103🇺🇸 Lexington, Kentucky, United States
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Site 109🇺🇸 Maitland, Florida, United States
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Site 102🇺🇸 Miami, Florida, United States
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Site 115🇺🇸 Peoria, Arizona, United States
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Site 104🇺🇸 Port Orange, Florida, United States
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Site 106🇺🇸 Rockville, Maryland, United States
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Site 100🇺🇸 Rogers, Arkansas, United States
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Site 101🇺🇸 San Antonio, Texas, United States
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Site 110🇺🇸 Tucson, Arizona, United States
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