The Role of the Amylin Analogue Cagrilintide in Bone Metabolism During Weight Loss in Postmenopausal Women With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)
研究概览
简要总结
In this study we will investigate how the medicine cagrilintide affects bone health in women after menopause with obesity during weight loss, compared to treatment with placebo (the dummy medicine with no active substances) and semaglutide. The purpose is to examine whether cagrilintide can reduce the decline in bone mass associated to weight loss. Participants will either get cagrilintide, semaglutide, CagriSema (cagrilintide combined with semaglutide) or placebo. Which treatment participants get is decided by chance. Semaglutide is already approved for the treatment of overweight and obesity and can be prescribed by doctors. Cagrilintide and CagriSema are new medications currently under development for weight management. The study will last for about 79 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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal at screening (defined as minimum 12 months of amenorrhea, high levels of follicular stimulating hormone (FSH) 16 - 130 international units per liter (IU/L), and low levels of anti-müllerian hormone (AMH) and inhibin B).
- •Age 50-70 years (both inclusive) at the time of signing the informed consent.
- •Body Mass Index (BMI) greater than or equal to >= 30.0 kilograms per square meter (kg/m^2).
排除标准
- •Previous or current bone disease (e.g., osteoporosis, Paget's disease of bone, or bone cancer).
- •Presence of disease affecting bone metabolism (e.g., diabetes mellitus, hyperparathyroidism, hyper or hypothyroidism, chronic kidney disease, celiac disease, or inflammatory diseases (e.g., psoriatic arthritis or ankylosing spondylitis)).
- •Treatment with any medication affecting bone metabolism within 6 months prior to screening as judged by the investigator (e.g., anti-resorptive medication, anabolic medication, systemic hormone replacement therapy (HRT), or systemic corticosteroids).
研究组 & 干预措施
CagriSema
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
干预措施: Placebo cagrilintide (Drug)
Cagrilintide
Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide or placebo at stepwise doses every 4 weeks in a 16-week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
干预措施: Cagrilintide (Drug)
Semaglutide
Participants will receive once-weekly s.c injections of semaglutide or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
干预措施: Semaglutide (Drug)
Semaglutide
Participants will receive once-weekly s.c injections of semaglutide or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
干预措施: Placebo semaglutide (Drug)
Placebo
Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks.
干预措施: Placebo cagrilintide (Drug)
Cagrilintide
Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide or placebo at stepwise doses every 4 weeks in a 16-week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
干预措施: Placebo cagrilintide (Drug)
CagriSema
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
干预措施: Cagrilintide (Drug)
CagriSema
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
干预措施: Semaglutide (Drug)
CagriSema
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
干预措施: Placebo semaglutide (Drug)
Placebo
Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks.
干预措施: Placebo semaglutide (Drug)
结局指标
主要结局
Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)
时间窗: From baseline to end of treatment (week 68)
Measured in percentage (%).
次要结局
- Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT(From baseline to end of treatment (week 68))
- Relative changes in vBMD of the radius assessed by QCT(From baseline to week 20)
- Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT(From baseline to week 20)
- Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - positron emission tomography (PET)(From baseline to end of treatment (week 68))
- Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - PET(From baseline to week 20)
- Relative changes in C-terminal telopeptide of type I collagen (CTX-1) and procollagen type 1 N-terminal propeptide (P1NP)(From baseline to end of treatment (week 68))
- Relative changes in CTX-1 and P1NP(From baseline to week 20)
- Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT)(From baseline to end of treatment (week 68))
- Relative changes in trabecular thickness assessed by PCCT(From baseline to end of treatment (week 68))
- Relative changes in number and separation of the femoral neck assessed by PCCT(From baseline to end of treatment (week 68))
- Relative changes in L1-L2 vertebrae assessed by PCCT(From baseline to end of treatment (week 68))
- Relative changes in radius assessed by PCCT(From baseline to end of treatment (week 68))
- Relative changes in vBMD of the radius assessed by QCT(From baseline to end of treatment (week 68))