CTRI/2023/04/051486进行中（未招募）3 期
Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutides.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight orobesity and type 2 diabetes
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 16
- 主要终点
- 1.Relative change in body weight
研究概览
简要总结
This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance.
The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female 2.Age above or equal to 18 years at the time of signing informed consent
- •BMI greather than or equal to 27.0 kg per m2
- •Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening 5.Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
- •Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
- •HbA1c below or equal to 10% (86 mmol/mol) as measured by the central laboratory at screening.
排除标准
- •1.Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness.
- •2.Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL per min per 1.73 m2 (below 45 mL per min per 1.73 m2 in participants treated with SGLT2i), as measured by the central laboratory at screening.
- •3.Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- •Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation.
- •Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
结局指标
主要结局
1.Relative change in body weight
时间窗: 1.Time Frame: | From baseline (week 0) to end of treatment | (week 68) | 2.Time Frame: From baseline | (week 0) to end of treatment (week 68)
weight reduction
时间窗: 1.Time Frame: | From baseline (week 0) to end of treatment | (week 68) | 2.Time Frame: From baseline | (week 0) to end of treatment (week 68)
2.Achievement of greater than or equal to 5percent
时间窗: 1.Time Frame: | From baseline (week 0) to end of treatment | (week 68) | 2.Time Frame: From baseline | (week 0) to end of treatment (week 68)
次要结局
- Relative change in body weight(Time Frame: From baseline (week 0) to week 20,Measured in percentage.)
- Change in waist circumference(Time Frame: From baseline (week 0) to end of treatment (week 68),Measured in cm)
- Change in Systolic Blood Pressure (SBP)(Time Frame: From baseline (week 0) to end of treatment (week 68),Measured in mmHg)
- Change in Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score(Time Frame: From baseline (week 0) to end of treatment (week 68) ,Score points)
- Achievement of more than or equal to 20 percent weight reduction(Time Frame: From baseline (week 0) to end of treatment (week 68) Count of participant)
- Change in Glycated Haemoglobin (HbA1c)(Time Frame: From baseline (week 0) to end of treatment (week 68) percentage-points)
- Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning score(Time Frame: From baseline (week 0) to end of treatment (week 68),Score points)
研究者
研究点 (16)
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