NCT02870231已完成1 期
A Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events
研究概览
简要总结
This trial is conducted in the United States of America. The aim of this trial is to investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.
- •Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
排除标准
- •Any clinically significant weight change (equal or above 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program within the last 90 days prior to screening
- •Any prior obesity surgery or currently present gastrointestinal implant.
- •Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
- •Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
- •Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
- •A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- •Calcitonin above or equal to 50 ng/L
- •History of pancreatitis (acute or chronic)
研究组 & 干预措施
NNC9204-0530 / Placebo and Liraglutide 1.8
Experimental
干预措施: NNC9204-0530 (Drug)
NNC9204-0530 / Placebo and Liraglutide 1.8
Experimental
干预措施: liraglutide (Drug)
NNC9204-0530 / Placebo and Liraglutide 1.8
Experimental
干预措施: placebo (Drug)
NNC9204-0530 /Placebo and Liraglutide 3.0
Active Comparator
干预措施: NNC9204-0530 (Drug)
NNC9204-0530 /Placebo and Liraglutide 3.0
Active Comparator
干预措施: liraglutide (Drug)
NNC9204-0530 /Placebo and Liraglutide 3.0
Active Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events
时间窗: Day 1-112
次要结局
- Change in HbA1C(Day -1, Day 85)
- Time to maximum serum concentration of NNC9204-0530(Day 84-112)
- Area under the NNC9204-0530 serum concentration-time curve(Day 84-112)
研究者
研究点 (1)
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