临床试验/NCT02835235

NCT02835235已完成1 期

A Double-blinded Placebo-controlled Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2016年7月26日最近更新: 2018年1月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 48
试验地点: 1
主要终点: Number of treatment emergent adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in the United States of America. The aim of the trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 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: Single Group
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

•Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
•Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.

排除标准

•Haemoglobin A1c (HbA1c) equal or above 6.5%
•Any clinically significant weight change (above or equal to 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.
•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)
•History of pancreatitis (acute or chronic)

研究组 & 干预措施

NNC9204-0530

Experimental

Dose-escalation within the cohort before reaching final dose

干预措施: NNC9204-0530 (Drug)

Placebo

Placebo 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

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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