A Phase 2, Randomized, Double-Blind, Dose-Range, Placebo-Controlled, 12-Week Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm D: Dose D
capsules dosed once daily in the morning
干预措施: Oral Placebo Matching BGE-102 (Drug)
Arm A: BGE-102 Dose A
capsules dosed once daily in the morning
干预措施: Oral BGE-102 (Drug)
Arm B: BGE-102 Dose B
capsules dosed once daily in the morning
干预措施: Oral BGE-102 (Drug)
Arm C: BGE-102 Dose C
capsules dosed once daily in the morning
干预措施: Oral BGE-102 (Drug)