A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,001
- 试验地点
- 179
- 主要终点
- Time to Onset of Obesity Related Complications or Class 1 Obesity
研究概览
简要总结
This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.
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
- •Have an increased waist-to-height ratio of ≥0.5
- •Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia)
- •Have at least one unsuccessful attempt to reduce body weight based on diet and exercise
- •Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds
排除标准
- •Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- •Do not have a stable body weight within 90 days before screening
- •Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold)
- •Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening
- •Have a prior or planned surgical treatment or procedure for obesity
- •Have hypertension or history of hypertension
- •Have dyslipidemia or history of dyslipidemia
研究组 & 干预措施
Placebo to Orforglipron
Participants will receive placebo orally followed by orforglipron orally
干预措施: Placebo (Drug)
Orforglipron to Placebo
Participants will receive orforglipron orally followed by placebo orally
干预措施: Placebo (Drug)
Placebo to Orforglipron
Participants will receive placebo orally followed by orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron to Placebo
Participants will receive orforglipron orally followed by placebo orally
干预措施: Orforglipron (Drug)
结局指标
主要结局
Time to Onset of Obesity Related Complications or Class 1 Obesity
时间窗: Baseline to Week 104
Obesity related complications defined as type 2 diabetes, hypertension, or dyslipidemia; Class 1 obesity defined as body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or an equivalent region-specific threshold
次要结局
- Percent Change from Baseline in Body Weight(Baseline, Week 104)
- Time to Onset of Waist-to-Height Ratio ≥0.6(Baseline to Week 104)
- Change from Baseline in Waist Circumference(Baseline, Week 104)
- Time to Onset of Class 1 Obesity(Baseline to Week 104)
- Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia(Baseline to Week 104)
- Time to Onset of Type 2 Diabetes(Baseline to Week 104)
- Percent Change from Baseline in Total Fat Mass(Baseline, Week 104)
- Change from Baseline in Systolic Blood Pressure(Baseline, Week 104)
- Change from Baseline in Glycated Hemoglobin (HbA1c)(Baseline, Week 104)
- Percent Change from Baseline in Triglycerides(Baseline, Week 104)
- Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score(Baseline, Week 104)
- Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron(Week 4, 12, 24, 52, and 76)