跳至主要内容
临床试验/jRCT2031250028
jRCT2031250028招募中不适用

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Amgen K.K.0 个研究点目标入组 3,501 人开始时间: 2025年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Amgen K.K.
入组人数
3,501
主要终点
-

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 Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Double Blind

入排标准

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

入选标准

  • Age >= 18 years.
  • Body mass index >= 30 kg/m2 or >= 27 kg/m2 to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

排除标准

  • Type 1 or Typ2 diabetes mellitus.
  • Obesity induced by other endocrinologic disorders.
  • Self-reported change in body weight > 5 kg within 90 days before screening.
  • Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type
  • History of chronic pancreatitis or History of acute pancreatitis within 180 days before screening.
  • History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
  • Lifetime history of suicide attempt.

结局指标

主要结局

-

1. Percent Change From Baseline in Body Weight at Week 72 [Time Frame: Baseline and Week 72]

次要结局

  • Change From Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72(Baseline and Week 72)
  • Percent Change From Baseline in Fasting Lipid Parameters at Week 72(Baseline and Week 72)
  • Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72(Baseline and Week 72)

研究者

发起方
Amgen K.K.

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