2026-526797-16-00招募中2 期
A study assessing the safety, tolerability, pharmacokinetics and efficacy of single and multiple doses of NNC0638-0355 in participants with overweight or obesity
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- 1. Relative change in body weight from baseline (week 0) to (week 26)
研究概览
简要总结
To compare the effect of multiple doses of NNC0638-0355 versus placebo on relative change in body weight from baseline (week 0) to week 26 in participants with overweight or obesity.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18-64 in Part F (both inclusive) at the time of signing the informed consent.
- •BMI between 27.0 and 39.9 kg/m2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Any condition, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
- •HbA1c ≥ 6.5% (48 mmol/mol) at screening.
- •Clinically significant abnormalities, as judged by the investigator, in vitamin D, PTH and total calcium, as determined by central laboratory at screening
结局指标
主要结局
1. Relative change in body weight from baseline (week 0) to (week 26)
1. Relative change in body weight from baseline (week 0) to (week 26)
次要结局
- 1. Change in body weight from baseline (week 0) to (week 26)
- 2. AUCSS; area under the NNC0638-0355 plasma concentration-time curve at steady state from first NC0638-0355 administation to 32 weeks.
- 3. CmaxSS; maximum observed NNC0638-0355 plasma concentration from first NC0638-0355 administation to 32 weeks.
研究者
Novo Nordisk A/S
Scientific
Novo Nordisk A/S
研究点 (1)
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