A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 5
- 主要终点
- Percent change from baseline in weight
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.
详细描述
This study is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study in adult participants with obesity. Approximately 70 participants will be randomized in a 1:1 ratio to GLY-200 (2.0 g, twice daily) or placebo (twice daily). There will be a ≤ 28-day screening period. Dosing will occur for 16 weeks. Clinic visits will occur at Screening, Week 0 (Day 1), and Weeks 1, 2, 4, 6, 8, 12, 16, and 17 [End of Study (EOS)] or Early Termination (ET). Phone visits will occur at Week 3, 10, and 14.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥ 18 and ≤ 70 years old at the time of screening
- •BMI ≥ 32 and ≤ 40 kg/m² at screening
排除标准
- •Known history of any form of diabetes mellitus, or HbA1c ≥6.5% (48 mmol/mol)
- •Participants who have had an increase or decrease in body weight more than 5% within the last 3 months
- •Treated with any prescription medication or procedure that promotes weight loss or weight gain in the last 6 months
- •Use of any drug treatment that affects gastric pH
- •Use of any drug treatment that affects gastrointestinal motility
- •Diagnosis or treatment of any symptomatic or structural abnormality of the GI tract or active disease within 12 months
- •Clinically significant symptoms (as determined by the Investigator) of nausea, vomiting, bloating, diarrhea, flatulence, constipation, or abdominal pain in the last 30 days
研究组 & 干预措施
GLY-200
Participants will receive 2.0 g GLY-200 orally twice daily for 16 weeks.
干预措施: GLY-200 (Drug)
Placebo
Participants will receive placebo (identical in appearance to GLY-200) orally twice daily for 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in weight
时间窗: Baseline and Week 16
Proportion of participants who achieve ≥ 5% body weight reduction
时间窗: Baseline and Week 16
次要结局
- Change and percent change from baseline in weight(Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16)
- Change from baseline in waist circumference(Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) considered by the Investigator to be related to study drug administration(Over the 16-week treatment period)