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
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