Effect of Once-weekly Subcutaneous Administration of NNC0487-0111 on Energy Intake, Appetite and Postprandial Metabolism in Participants With Obesity - a Randomised, Placebo-controlled, Double Blinded Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126
研究概览
简要总结
The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex at birth).
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •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.
- •Overweight should be due to excess adipose tissue, as judged by the investigator.
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- •History of type 1 or type 2 diabetes mellitus.
- •Glycated hemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) at screening.
- •Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issues.
- •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.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
研究组 & 干预措施
NNC0487-0111
Participants will be randomized to receive 1 of the different dose levels of NNC0487-0111 subcutaneously once weekly.
干预措施: NNC0487-0111 (Drug)
Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly.
干预措施: Placebo (matched to NNC0487-0111) (Drug)
结局指标
主要结局
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126
时间窗: From Baseline to Day 126
Measured as percentage change of energy.
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182
时间窗: From Baseline to Day 182
Measured as percentage change of energy.
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238
时间窗: From Baseline to Day 238
Measured as percentage change of energy.
次要结局
- Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126(From Baseline to Day 126)
- Relative change from Day 19 in body weight to Day 383(From Day 19 to Day 383)
- Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182(From Baseline to Day 182)
- Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238(From Baseline to Day 238)
- Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126(From Baseline to Day 126)
- Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 182(From Baseline to Day 182)
- Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 238(From Baseline to Day 238)
- Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 378(From Baseline to Day 378)
- Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box at Day 378(From Baseline to Day 378)
- Change from baseline in total amount of food consumed during ad libitum breakfast, lunch, evening meal and snack box to Day 378(From Baseline to Day 378)
- Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 126(From Baseline to Day 126)
- Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 182(From Baseline to Day 182)
- Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 238(From Baseline to Day 238)
- Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 378(From Baseline to Day 378)
- Relative change from Day 19 in body weight to Day 131(From Day 19 to Day 131)
- Relative change from Day 19 in body weight to Day 187(From Day 19 to Day 187)
- Relative change from Day 19 in body weight to Day 243(From Day 19 to Day 243)