An Investigation of the Effect of Cagrilintide and Semaglutide Combination Treatment (CagriSema) on Appetite and Functional Brain Activity in People With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Change in mean postprandial appetite score based on visual analogue scale (VAS)
研究概览
简要总结
Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months.
Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged 18-65 years (both inclusive) at the time of signing informed consent
- •Right-handed as evaluated by the Edinburgh Handedness Inventory
- •Body weight less than or equal to 180 kilogram at screening
- •For Part A:
- •A score of 7 or less on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
- •Body mass index between 18.5 and 24.9 kilogram per meter square (both inclusive) at screening
- •For Part B:
- •A score of 8 or more on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
- •Body mass index equal to or above 27.0 kilogram per meter square. Overweight should be due to excess adipose tissue, as judged by the investigator
排除标准
- •Contraindication for magnetic resonance scanning
- •For Part B:
- •Glycated haemoglobin greater than or equal to 6.5 % (48 millimoles per mole) at screening
- •History of type 1 or type 2 diabetes mellitus
研究组 & 干预措施
Part A
Participants will not get any medicine during this study.
干预措施: No treatment given (Other)
Part B
Participants will receive CagriSema or placebo (Dose 1,2,3,4) for 16-weeks dose-escalation period followed by 37-weeks intervention period on CagriSema or placebo (Dose 5) that includes a 12-day standardised energy intake period.
干预措施: Cagrilintide and Semaglutide (Drug)
Part B
Participants will receive CagriSema or placebo (Dose 1,2,3,4) for 16-weeks dose-escalation period followed by 37-weeks intervention period on CagriSema or placebo (Dose 5) that includes a 12-day standardised energy intake period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in mean postprandial appetite score based on visual analogue scale (VAS)
时间窗: Baseline to week 24
Measured in millimeter. VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best.
次要结局
- Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption(Baseline to week 24)
- Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score(Baseline pre-treatment ((Day 4 - Day 10) to treatment (Day 156 - Day 162)))
- Change in control of eating questionnaire (COEQ), 4 domains: craving control score, positive mood score, craving for sweets score and craving for savoury food score(Baseline to week 24)
- Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas(Baseline to week 24)
- Relative change in total energy intake during ad libitum lunch, evening meal and snackbox(Baseline to week 24)
- Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box(Baseline to week 24)
- Change in total energy intake during ad libitum lunch, evening meal and snackbox(Baseline to week 24)
- Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox(Baseline to week 24)
- Change in body weight(Baseline to week 24)
- Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score(Baseline to week 24)