NCT07339423招募中3 期
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,150
- 试验地点
- 72
- 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 NNC0487-0111 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 NNC0487-0111 (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)
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).
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
排除标准
- •HbA1c ≥ 6.5% (48 millimole 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
NNC0487-0111
Experimental
Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: NNC0487-0111 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
干预措施: Placebo (matched to NNC0487-0111) (Drug)
结局指标
主要结局
Relative change in body weight
时间窗: From baseline (week 0) to week 84
Measured as percentage of body weight.
次要结局
- Change in waist circumference(From baseline (week 0) to week 84 and week 136)
- Change in systolic blood pressure (SBP)(From baseline (week 0) to week 84 and week 136)
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score(From baseline (week 0) to week 84 and week 136)
- Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score(From baseline (week 0) to week 84 and week 136)
- Change in body weight(From baseline (week 0) to week 84 and week 136)
- Change in body mass index (BMI)(From baseline (week 0) to week 84 and week 136)
- Change in IWQOL-Lite-CT physical composite score(From baseline (week 0) to week 84 and week 136)
- Change in IWQOL-Lite-CT psychosocial composite score(From baseline (week 0) to week 84 and week 136)
- Change in IWQOL-Lite-CT total score(From baseline (week 0) to week 84 and week 136)
- Change in glycated haemoglobin (HbA1c)(From baseline (week 0) to week 84 and week 136)
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to week 84 and week 136)
- Ratio to baseline: change in fasting insulin(From baseline (week 0) to week 84 and week 136)
- Change in diastolic blood pressure (DBP)(From baseline (week 0) to week 84)
- Ratio to baseline: change in total cholesterol(From baseline (week 0) to week 84 and week 136)
- Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to week 84 and week 136)
- Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to week 84 and week 136)
- Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to week 84 and week 136)
- Ratio to baseline: change in non-HDL cholesterol(From baseline (week 0) to week 84 and week 136)
- Ratio to baseline: change in triglycerides(From baseline (week 0) to week 84 and week 136)
- Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)(From baseline (week 0) to week 84 and week 136)
- Number of treatment emergent adverse events (TEAEs)(From baseline (week 0) to week 84 and week 140)
- Number of treatment emergent serious adverse events (TESAEs)(From baseline (week 0) to week 84 and week 140)
- Number of TEAEs leading to permanent treatment discontinuation(From baseline (week 0) to week 84 and week 140)
- Relative change in body weight(From baseline (week 0) to week 136)
研究者
研究点 (72)
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