A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors
Purpose
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.
Condition
- Obesity and Cardiovascular Risk
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: BGE-102 Dose A |
capsules dosed once daily in the morning |
|
|
Experimental Arm B: BGE-102 Dose B |
capsules dosed once daily in the morning |
|
|
Experimental Arm C: BGE-102 Dose C |
capsules dosed once daily in the morning |
|
|
Placebo Comparator Arm D: Dose D |
capsules dosed once daily in the morning |
|
Recruiting Locations
Chandler, Arizona 85225
Peoria, Arizona 85381
Tucson, Arizona 85711
Rogers, Arkansas 72758
Maitland, Florida 32751
Miami, Florida 33172
Port Orange, Florida 32127
Rockville, Maryland 20854
Kansas City, Missouri 64131
San Antonio, Texas 78240
San Juan, Puerto Rico 00927
More Details
- Status
- Recruiting
- Sponsor
- BioAge Labs, Inc.
Detailed Description
The purpose of this study is to assess the pharmacodynamics and safety of oral once a day (QD) dosing of BGE-102 at 3 dose levels compared to placebo over 12 weeks of treatment. Study details include: - The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks). - The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16. - The treatment duration will be up to 12 weeks. BGE-102 will be given as Dose A, Dose B or Dose C QD capsules or placebo QD capsules for the entire 12-week treatment period.