A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared with Placebo in Adult Participants with Obesity or Overweight with Weight-Related Comorbidities (ATTAIN-1)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
- 试验地点
- 10
- 主要终点
- Mean Percent Change from Baseline in Body Weight
研究概览
简要总结
From 1998 to 2018, the prevalence of obesity is rapidly spurting due to sedentary lifestyle and consumption of high calories food. In India, more than 135 million individuals were affected by obesity. Treatment with glucagon-like peptide-1 receptor agonist and dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonists has shown body weight reduction of a greater magnitude compared to conventional pharmacologic anti-obesity therapies. Despite these advancements, bariatric surgery, such as RY-gastric bypass or sleeve gastrectomy remains the only approved treatment that achieves average body weight reduction of 30 to 32%. There remains an unmet medical need for pharmacologic treatments that are safe, efficacious, and well tolerated in patients with overweight and obesity. Hence, this study which aims to investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities is hopeful to clarify its safety and efficacy in order to be considered as a potential treatment candidate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Have a BMI ≥30.0 kilogram/square meter (kg/m²), or ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening: Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
排除标准
- •Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- •Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
- •Have family (first-degree relative) or personal history of MTC or MEN2 syndrome.
- •Have had a history of chronic or acute pancreatitis.
结局指标
主要结局
Mean Percent Change from Baseline in Body Weight
时间窗: Baseline to Week 72
次要结局
- 1. Mean Change from Baseline in Waist Circumference(2. Mean Change from Baseline in Systolic Blood Pressure (SBP))