A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Obese or Overweight Subjects Without Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 13
- 主要终点
- Percent Change in Body Weight.
研究概览
简要总结
This Study is a Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Obese or Overweight Subjects Without Diabetes Mellitus.
详细描述
HM-OBCT-201 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel group study designed to evaluate the efficacy, safety, and tolerability of HM15275 treatment over 36 weeks in obese or overweight adults without Type 2 diabetes mellitus (T2DM).
The study will enroll adult participants with obesity (body mass index [BMI] ≥30 kg/m2 and ≤50 kg/m2) or with overweight (BMI ≥27 kg/m2 and <30 kg/m2) with at least 1 weight-related comorbidity. Patients with T2DM will be excluded.
Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms. Randomization will be stratified by sex (female vs male) and BMI (<35 vs ≥35 kg/m2).
All participants will undergo a 6-week screening period, a 36-week treatment period (including the dose-titration phase with weekly subcutaneous [SC] injection), and a 4-week safety follow-up 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Treatment assignment will remain blinded to participants, investigators/study personnel, and sponsor's study team conducting the study. Participants who meet all criteria for enrollment will be centrally assigned randomized to study drug using an Interactive Web Response System (IWRS).
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Type 1 diabetes mellitus or T2DM, or HbA1c ≥6.5% / FPG ≥126 mg/dL
- •Obesity due to endocrine/genetic disorders
- •Planned or prior obesity surgery (unless >1 year ago for liposuction/abdominoplasty), or device-based obesity therapy (unless removed >6 months ago)
- •Personal history or current diagnosis of acute or chronic pancreatitis or factors that may increase the risk of pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse.
- •Personal or family history of medullary thyroid carcinoma (MTC) or a known genetic condition (e.g., multiple endocrine neoplasia type 2) that predisposes the participant to MTC.
- •Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- •History or current diagnosis of congestive heart failure (NYHA class Ⅲ or Ⅳ), or myocardial infarction, stroke, unstable angina, transient ischemic attack, or revascularization procedure (e.g., stent or bypass graft surgery) within 3 months prior to screening visit
- •Personal history or current diagnosis of acute or chronic pancreatitis or factors that may increase the risk of pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse.
研究组 & 干预措施
HM15275
Participants will receive HM15275 via subcutaneous (SC) injection.
干预措施: HM15275 (Drug)
Placebo of HM15275
Participants will receive placebo of HM15275 via subcutaneous (SC) injection.
干预措施: Placebo of HM15275 (Drug)
结局指标
主要结局
Percent Change in Body Weight.
时间窗: Up to 41 weeks
Percent change in body weight from Week 1 to Week 37, measured using a standardized, calibrated scale under fasting conditions.
次要结局
- Number of participants with adverse events (AEs)(Up to 41 weeks)