跳至主要内容
临床试验/2023-503659-88-00
2023-503659-88-00招募中3 期

J1I-MC-GZBM: A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants with Severe Obesity and Established Cardiovascular Disease (TRIUMPH-3)

Eli Lilly & Co.43 个研究点 分布在 4 个国家目标入组 389 人开始时间: 2023年8月22日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
389
试验地点
43
主要终点
Percent Change from Baseline in Body Weight

研究概览

简要总结

The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD).

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

  • Have obesity.
  • Have established heart disease.
  • Have history of unsuccessful dietary weight loss effort

排除标准

  • have had the following within 90 days before screening: heart attack, stroke, a procedure to get blood flowing back into the heart, or been hospitalized for either congestive heart failure or sudden chest pain because of a blood clot in the heart
  • Have been taking weight loss drugs, including over-the-counter medications, within 90 days before screening
  • Have a self-reported change in body weight greater than 11 pounds within 90 days before screening.
  • have undergone weight loss surgery (e.g. stomach stapling, lap banding) within 1 year before screening
  • Have Type 1 diabetes
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Have had chronic or acute pancreatitis

结局指标

主要结局

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 (43)

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