A First Human Dose Study Investigating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single and Multiple Ascending Doses of NNC6989-0001 in Healthy Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAE) - Part A
研究概览
简要总结
This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of non-childbearing potential.
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m^2 for Part B (MAD part) and Part C (meal timing and potentially meal composition).
- •Considered eligible 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
- •Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
- •Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
- •Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.
结局指标
主要结局
Number of treatment emergent adverse events (TEAE) - Part A
时间窗: From time of dosing on Day1 until completion of the end of study visit (Day 7)
Measure in number of events.
Number of treatment emergent adverse events (TEAE) - Part B
时间窗: From time of dosing on Day 1 until completion of the end of study visit (Day 14)
Measured in number of events
iAUCTG; The incremental area under the blood triglycerides concentration-time curve following meal test - Part C
时间窗: Following meal test at Day -1, Day 1, Day 7 and Day 13
Measured in ratio
次要结局
- AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A(From pre-dose on Day 1 until completion of the end of study visit (Day 7))
- Cmax; the maximum plasma concentration of NNC6989-0001 - Part A(From pre-dose on Day 1 until completion of the end of study visit (Day 7))
- AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B(From pre-dose on Day 1 until completion of the end of study visit (Day 14))
- Cmax; the maximum plasma concentration of NNC6989-0001 - Part B(From pre-dose on Day 1 until completion of the end of study visit (Day 14))
- AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part C(From pre-dose on Day 1 until completion of the end of study visit (Day 20))
- Cmax; the maximum plasma concentration of NNC6989-0001 - Part C(From pre-dose on Day 1 until completion of the end of study visit (Day 20))