跳至主要内容
临床试验/jRCT2031250803
jRCT2031250803尚未招募不适用

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes (J3R-MC-YDAL)

未提供0 个研究点目标入组 900 人开始时间: 待定
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
900

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • Are on stable incretin therapy at screening
  • With persistent obesity or overweight defined as:
  • >=30 kg/m2 OR
  • >=27 kg/m2 with at least one existing obesity related complication at screening:
  • hypertension
  • dyslipidemia
  • obstructive sleep apnea
  • cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
  • type 2 diabetes
  • Have a stable body weight (<5% body weight change) at screening

排除标准

  • Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)
  • Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
  • Have type 1 diabetes
  • Have taken any of the following antihyperglycemic medications within 90 days before screening:
  • dipeptidyl peptidase-4 (DPP-4) inhibitors
  • amylin analogs
  • Have had within 90 days prior to screening:
  • heart attack
  • coronary artery revascularization
  • unstable angina, or
  • hospitalization due to congestive heart failure
  • Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure

研究者

发起方
未提供

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