NCT07557953招募中1 期
A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity
适应症
干预措施
相关药物
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 in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
研究概览
简要总结
The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.
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.
- •Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
- •Considered to be generally healthy, except for overweight or obesity, 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
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- •Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening.
- •History of type 1 or type 2 diabetes mellitus
- •Any clinically significant body weight change (≥ 5% self-reported change) or dieting at-tempts (e.g., participation in a weight reduction program) within 90 days before screening.
- •Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues.
- •Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening.
- •Previous dosing of marketed or non-marketed amylin-based compounds.
研究组 & 干预措施
Cagrilintide
Experimental
Participant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks.
干预措施: Cagrilintide (Drug)
Placebo Cagrilintide
Placebo Comparator
Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 weeks.
干预措施: Placebo Cagrilintide (Drug)
结局指标
主要结局
Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
时间窗: From baseline (Day 2) to end of treatment (Day 127)
Measured in percentage (%).
次要结局
- Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box(From baseline (Day 2) to end of treatment (Day 127))
- Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box(From baseline (Day 2) to end of treatment (Day 127))
- Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box(From baseline (Day 2) to end of treatment (Day 127))
- Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS)(From baseline (Day 1) to end of treatment (Day 126))
- Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption(From baseline (Day 1) to end of treatment (Day 126))
- Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness(From baseline (Day 1) to end of treatment (Day 126))
- Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS(From baseline (Day 1) to end of treatment (Day 126))
- • Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score(From baseline (Day -1) to end of treatment (Day 125))
- Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score(From baseline (Day -1) to end of treatment (Day 125))
研究者
研究点 (1)
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