NCT07607587招募中1 期
Tolerability of Cagrilintide in People With Obesity That Discontinued GLP-1-RA Therapies Due to Gastrointestinal Adverse Events: a Double-blinded Randomised Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 11
研究概览
简要总结
The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.
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)
入排标准
- 年龄范围
- 18 Years 至 —（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 18 years or above at the time of signing the informed consent
- •History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation
- •Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement
- •Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m^2)
排除标准
- •Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods
- •Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening
- •History of type 1 or type 2 diabetes
- •Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening
- •Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening
- •Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo matched to Cagrilintide for 26 weeks.
干预措施: Placebo (matched to Cagrilintide) (Drug)
Cagrilintide
Experimental
Participants will receive Cagrilintide for 26 weeks.
干预措施: Cagrilintide (Drug)
研究者
研究点 (11)
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