2023-503657-35-00招募中3 期
J1I-MC-GZBJ: A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1); J1I-MC-GOA1: Indication-Specific Appendix (ISA2) for participants with knee osteoarthritis (OA)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 36
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1)
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
- •Be overweight
- •Have history of unsuccessful dietary weight loss effort
- •(GOA1) Have index knee pain for >12 weeks prior to screening and at least one of the following (GOA1) Age >50 years (GOA1) Morning stiffness in the index knee less than 30 minutes in duration (GOA1) Crepitus in the index knee
排除标准
- •Have a self-reported or documented change in body weight > 5kg within 90 days prior to screening
- •(GOA1) Pain from another location with radiation to the knee (for example, hip pain referred to the knee, radicular pain)
- •(GOA1) Knee infection
结局指标
主要结局
Percent Change from Baseline in Body Weight
Percent Change from Baseline in Body Weight
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
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 (36)
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