跳至主要内容
临床试验/2023-503660-17-00
2023-503660-17-00招募中3 期

J1I-MC-GZBN:A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants who have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial

Eli Lilly & Co.8 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
入组人数
65
试验地点
8
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 LY3437943 9 mg and/or 12 mg QW is superior to placebo for: change in the WOMAC Pain subscale AND change in bodyweight.

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

入选标准

  • Be overweight.
  • Have a history of 1 self-reported unsuccessful dietary effort to lose body weight.
  • Have knee pain prior to screening more than 12 weeks

排除标准

  • Have a change in body weight greater than 11 pounds
  • Prior joint replacement in the index knee
  • Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes.

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

Percent Change from Baseline in Body Weight

Percent Change from Baseline in Body Weight

次要结局

未报告次要终点

研究者

申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

Lilly Clinical Trials information desk

Scientific

Eli Lilly & Co.

研究点 (8)

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