2023-506931-13-00已完成3 期
Efficacy and safety of cagrilintide s.c. in combination with semaglutide s.c. (CagriSema s.c.) once-weekly in participants with overweight or obesity and type 2 diabetes
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 40
- 主要终点
- Relative change in body weight
研究概览
简要总结
To confirm superiority on body weight reduction of CagriSema versus placebo as adjunct to reduced-calorie diet and increased physical activity in participants with overweight or obesity and T2D.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age above or equal to 18 years at the time of signing informed consent
- •BMI ≥ 27.0 kg/m2
- •Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening
- •Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 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 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening
排除标准
- •Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- •Renal impairment with estimated glomerular filtration rate (eGFR)< 30 mL/min/1.73 m2, as measured by the central laboratory at screening
- •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
研究组 & 干预措施
cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide
Test
干预措施: cagrilintide semaglutide (Drug)
Placebo + Placebo
Placebo
干预措施: Placebo + Placebo (Drug)
结局指标
主要结局
Relative change in body weight
Relative change in body weight
Achievement of ≥ 5% weight reduction
Achievement of ≥ 5% weight reduction
次要结局
- Achievement of ≥ 20% weight reduction
- Relative change in body weight
- Change in waist circumference
- Change in Glycated Haemoglobin (HbA1c)
- Change in Systolic Blood Pressure (SBP)
- Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
- Change in SF-v2 Health Survey Acute (SF-36v2 Acute) Physical Functioning score
- Number of Treatment Emergent Adverse Events (TEAEs)
- Number of Treatment Emergent Serious adverse events (TESAEs)
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)
- Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (40)
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