A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 22
- 主要终点
- Mean percent change from baseline in body weight
研究概览
简要总结
The aim of this study is to evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in participants who have obesity or overweight with weight-related comorbidities.
详细描述
This is a randomized, double-blind, placebo-controlled study of oral ecnoglutide (VRB-101), with 5 active arms and 1 placebo arm. The study will include a Screening Period of 4 weeks, followed by a 20-week Study Treatment Period and a 4-week Safety Follow-up Period prior to the end of study (EOS) visit.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have hemoglobin A1c (HbA1c) <6.5%.
- •Have a BMI of ≥30 kg/m2 OR ≥27 kg/m2 and <30 kg/m2 with at least 1 weight-related comorbidity.
- •Have a self-reported history of stable body weight for the 3 months prior to randomization (≤5% body weight change).
- •Participants of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
排除标准
- •Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), or other forms of diabetes mellitus. A participant with a history of gestational diabetes may be included in the study if the participant has an HbA1c < 6.5% at Screening.
- •Have at least 1 laboratory value suggestive of diabetes during Screening, including 1 or more of HbA1c ≥6.5% (48 mmol/mol) or random glucose ≥200 mg/dL (11.1 mmol/L).
- •Have had exposure to glucagon-like peptide -1 (GLP-1) 6 months prior to Screening or any prior history of known or suspected hypersensitivity/allergies, intolerability, or lack of efficacy to these medications. Have known or suspected hypersensitivity to study intervention(s), to selective GLP-1 receptor agonist (RA) or glucose-dependent insulinotropic peptide (GIP)/GLP-1 or GLP-1/glucagon (GCG) dual receptor agonists.
- •Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time within the dosing period, including follow -up, and for at least 60 days after the last dose of study intervention.
研究组 & 干预措施
Schedule A: VRB-101 (Active Arm 1)
Participants will receive VRB-101 once every week.
干预措施: VRB-101 (Drug)
Schedule A: VRB-101 (Active Arm 2)
Participants will receive VRB-101 once every week.
干预措施: VRB-101 (Drug)
Schedule B: VRB-101 (Active Arm 4)
Participants will receive VRB-101 once every week.
干预措施: VRB-101 (Drug)
Schedule B: VRB-101 (Active Arm 5)
Participants will receive VRB-101 once every week.
干预措施: VRB-101 (Drug)
Pooled Placebo
Participants will receive matching placebo to VRB-101 once every week.
干预措施: Placebo (Drug)
Schedule A: VRB-101 (Active Arm 3)
Participants will receive VRB-101 once every week.
干预措施: VRB-101 (Drug)
结局指标
主要结局
Mean percent change from baseline in body weight
时间窗: From Baseline (Day 0) up to Week 21
To evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in Schedule A dose regimens.
次要结局
- Absolute change from baseline in body weight(From Baseline (Day 0) up to Week 21)
- Percentage of participants who achieve 5% or more body weight reduction(From Baseline (Day 0) up to Week 21)
- Change from baseline in body mass index (BMI)(From Baseline (Day 0) up to Week 21)
- Number of study participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)(From Baseline (Day 0) up to Week 24)
- Change from baseline in blood pressure (BP)(From Baseline (Day 0) up to Week 24)
- Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)(From Baseline (Day 0) up to Week 21)