Efficacy and Safety of Zenagamtide s.c. Once-weekly in Asian Participants With Overweight or Obesity (AMAZE 13)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 44
研究概览
简要总结
The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex assigned at birth, inclusive of all gender identities).
- •Age 18 years or above at the time of signing the informed consent
排除标准
- •Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes mellitus.
- •Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.
研究组 & 干预措施
Placebo
Participants will receive placebo matched to Zenagamtide subcutaneously once weekly.
干预措施: Placebo ( matched to Zenagamtide) (Drug)
Zenagamtide
Participants will be randomized to receive 1 out of 3 different dose levels subcutaneously once weekly.
干预措施: Zenagamtide (Drug)