Single-centre Study Investigating the Role of Long-acting Subcutaneous Glucose-dependent Insulinotropic Polypeptide Receptor Agonist (GIP RA) in Combination With Long-acting Subcutaneous Amylin Receptor Agonist on Gastrointestinal Tolerability in Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea
研究概览
简要总结
This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone. In one period participants will get two medicines: cagrilintide and NNC0480-0389. In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it. Cagrilintide and NNC0480-0389 is a new medicine being tested to help people with type 2 diabetes and/or overweight or obesity. The trial medicines is not yet approved for use outside of clinical trials. Participants will receive the trial medicines the way the trial doctor has described. The study will last for about 4.5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at birth.
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 27.0 kilograms per square meter (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening.
- •Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Considered eligible with suitable veins for cannulation or repeated venepuncture, as judged by the investigator.
- •No clinically significant findings during medical history, physical examination, vital signs, electrocardiogram or clinical laboratory tests at the screening visit, as assessed 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 highly effective contraceptive method.
- •Current participation (i.e., dosing) in any other interventional clinical study within 90 days before screening.
- •Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, including incretin-based treatment(s).
- •Previous or planned (during the study period) obesity treatment with surgery. However, the following are allowed:
- •Liposuction and/or abdominoplasty, if performed greater than symbol (>) 1 year before screening.
- •Adjustable gastric banding, if the band has been removed > 1 year before screening.
- •Intragastric balloon, if the balloon has been removed > 1 year before screening.
- •Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed > 1 year before screening.
研究组 & 干预措施
Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide
Participants will receive low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
干预措施: Glucose-dependent Insulinotropic Polypeptide (GIP) (Drug)
Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide
Participants will receive low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
干预措施: Placebo GIP (Drug)
Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide
Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 2.
干预措施: Glucose-dependent Insulinotropic Polypeptide (GIP) (Drug)
Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide
Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 2.
干预措施: Placebo GIP (Drug)
Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide
Participants will receive high dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
干预措施: Glucose-dependent Insulinotropic Polypeptide (GIP) (Drug)
Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide
Participants will receive high dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
干预措施: Placebo GIP (Drug)
Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide
Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by medium dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 2.
干预措施: Glucose-dependent Insulinotropic Polypeptide (GIP) (Drug)
Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide
Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by medium dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 2.
干预措施: Placebo GIP (Drug)
Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide
Participants will receive high dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
干预措施: Cagrilintide (Drug)
Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide
Participants will receive low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
干预措施: Cagrilintide (Drug)
Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide
Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 2.
干预措施: Cagrilintide (Drug)
Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide
Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by medium dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 2.
干预措施: Cagrilintide (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea
时间窗: From first investigational medicinal products (IMP) administration (visit 2, day 1 or visit 9, day 74) to the end of treatment visit (Visit 2, day 16 or Visit 9, day 89)
Measured as number of events.
次要结局
- Total number of Adverse Events(First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142))