A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 751
- 试验地点
- 32
- 主要终点
- Percent Change From Baseline in Body Weight
研究概览
简要总结
The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.
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
- None
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 a body mass index (BMI) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- •Have a history of at least 1 unsuccessful dietary effort to lose body weight
排除标准
- •Diabetes mellitus
- •Change in body weight greater than 5 kg within 3 months prior to starting study
- •Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- •History of pancreatitis
- •Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
研究组 & 干预措施
15 mg or MTD - Tirzepatide
Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or maximum tolerated dose [MTD (10 mg or 15 mg)] until Week 72.
干预措施: Tirzepatide (Drug)
2.4 mg or MTD - Semaglutide
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight
时间窗: Baseline, Week 72
Percent change from baseline in body weight was reported. Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.
次要结局
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Week 72)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Week 72)
- Percentage of Participants Who Achieve ≥20% Body Weight Reduction(Week 72)
- Percentage of Participants Who Achieve ≥25% Body Weight Reduction(Week 72)
- Change From Baseline in Waist Circumference in Centimeter(Baseline, Week 72)
- Percentage of Participants Who Achieve ≥30% Body Weight Reduction(Week 72)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 72)
- Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide(Baseline, Week 72)