A Study Investigating Safety, Tolerability and Efficacy of Once-weekly NNC0662-0419 in Participants Living With Overweight or Obesity
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
- 试验地点
- 4
- 主要终点
- Part B: Relative change in body weight
研究概览
简要总结
This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study treatments in this study, participants will get either NNC0662-0419, the treatment being tested or placebo, a treatment that has no active medicine in it. NNC0662-0419 is a new medicine which cannot be pre-scribed by doctors but has previously been tested in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex at birth).
- •Age at the time of signing the informed consent:
- •For Part A:18-55 years (both inclusive)
- •For Part B and Part C: 18-65 years (both inclusive)
- •Body Mass Index (BMI) at screening (overweight should be due to excess adipose tissue, as judged by the investigator):
- •For Part A: 27.0-39.9 kilogram per square meter(kg/m^2) (both inclusive)
- •For Part B and Part C:
- •Greater than or equal to (≥) 27.0 kg/m^2 with the presence of at least one weight-related comorbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease), or
- •Greater than or equal to (≥) 30.0 kg/m^2
- •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.
- •Willingness to obtain a high weight loss (greater than [>] 25 percent [%]).
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Treatment with any compound containing Glucagon-Like Peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or amylin receptor agonism within 90 days before screening.
- •Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- •2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 millisecond (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening.
- •Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimoles per mole [mmol/mol]) at screening.
- •History of type 1 or type 2 diabetes mellitus.
- •Calcitonin greater than or equal to (≥) 50 nanogram per litre (ng/L) at screening.
研究组 & 干预措施
Placebo
Participant will be randomized to receive placebo in:
The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
干预措施: Placebo (Drug)
NNC0662-0419
Participants will be randomized to receive NNC0662-0419 subcutaneously (s.c.). The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
干预措施: NNC0662-0419 (Drug)
结局指标
主要结局
Part B: Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 36)
Measured as percentage (%).
Part C: Occurrence of premature treatment discontinuation (Yes/No)
时间窗: At end of treatment (week 24)
Measured as count of participants.
Part A: Number of treatment-emergent adverse events (TEAE)
时间窗: From baseline (week 0) to end of study (up to week 44)
Measured as number of events.
Part B: Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 36)
Measured as percentage (%).
Part C: Occurrence of premature treatment discontinuation (Yes/No)
时间窗: At end of treatment (week 24)
Measured as count of participants.
次要结局
- Part B: Body weight reduction ≥ 15% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction ≥ 20% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction ≥ 25% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Number of treatment emergent adverse events (TEAE)(From baseline (week 0) to end of study (week 39))
- Part C: Number of treatment emergent adverse events (TEAE)(From baseline (week 0) to end of study (week 27))
- Part A: Relative change in body weight(From baseline (week 0) to end of treatment (up to week 40))
- Part A: Change in body weight(From baseline (week 0) to end of treatment (up to week 40))
- Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve(From pre-dose on day 1 to completion of the end of study visit (up to week 44))
- Part A: Cmax; the maximum plasma concentration of NNC0662-0419(From pre-dose on day 1 to completion of the end of study visit (up to week 44))
- Part B: Change in body weight(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction greater than or equal to (≥) 5% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction ≥ 10% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Number of treatment emergent adverse events (TEAE)(From baseline (week 0) to end of study (week 39))
- Part C: Number of treatment emergent adverse events (TEAE)(From baseline (week 0) to end of study (week 27))
- Part A: Relative change in body weight(From baseline (week 0) to end of treatment (up to week 40))
- Part A: Change in body weight(From baseline (week 0) to end of treatment (up to week 40))
- Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve(From pre-dose on day 1 to completion of the end of study visit (up to week 44))
- Part A: Cmax; the maximum plasma concentration of NNC0662-0419(From pre-dose on day 1 to completion of the end of study visit (up to week 44))
- Part B: Change in body weight(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction greater than or equal to (≥) 5% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction ≥ 10% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction ≥ 15% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction ≥ 20% (Yes/No)(From baseline (week 0) to end of treatment (week 36))
- Part B: Body weight reduction ≥ 25% (Yes/No)(From baseline (week 0) to end of treatment (week 36))