Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 950
- 试验地点
- 78
- 主要终点
- Relative change in body weight
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 oral tablets once a day. Participants will either get zenagamtide (the treatment being tested) or Placebo (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 at birth).
- •Age 18 and older (both inclusive) at time of signing the informed consent.
排除标准
- •Glycated haemoglobin (HbA1c) more than or equal to (≥) 6.5% [48 millimoles per mole (mmol/mol)] as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
- •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 orally once daily as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Placebo (Drug)
zenagamtide
Participants will be randomized to receive 1 of the 5 dose levels of zenagamtide orally once daily as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: zenagamtide (Drug)
结局指标
主要结局
Relative change in body weight
时间窗: From baseline (week 0) to (week 76)
Measured as percentage (%) change in body weight.
次要结局
- Change in waist circumference(From baseline (week 0) to (week 76))
- Change in systolic blood pressure (SBP)(From baseline (week 0) to (week 76))