Obesity and Cardiovascular Risk
Conditions
Keywords
Obesity, Cardiovascular, BGE-102, hsCRP, BioAge, NLRP3
Brief 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.
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.
Interventions
DRUGOral BGE-102
Capsules
Capsules
Sponsors
BioAge Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs) | Up to Week 16 |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to Week 16 |
Countries
Puerto Rico, United States
Outcome results
None listed