2025-522631-34-00招募中3 期
J2A-MC-GZPT A Phase 3 Study to Investigate the Efficacy and Safety of Orfor-glipron Once Daily in Participants Who Have Obesity or Overweight and Osteoar-thritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Pla-cebo-Controlled Trial List of Intervention-Specific Appendices (ISAs): ISA1 (GZT1): A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee ISA2 (GZT2): A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 12
- 主要终点
- Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
研究概览
简要总结
To demonstrate that orforglipron once daily maximum tolerated dose (MTD) is superior to placebo for change in the WOMAC pain subscale score.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Have obesity or overweight
- •Have tried to lose weight through diet at least once but were not successful
- •Have osteoarthritis of the knee
- •Be willing to stop certain pain medications during the entire study
排除标准
- •Have taken a glucagon-like peptide-1 (GLP-1) medication within 180 days or other weight loss medications in the 90 days before screening.
- •Have type 1 or type 2 diabetes or another type of diabetes
- •Be taking a medicine to lower blood sugar in the 90 days before screening.
- •Have had a recent heart attack, stroke or other heart event in the 90 days before screening
- •Have had surgery for obesity or plan to have one in the next 18 months
结局指标
主要结局
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (12)
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