NCT06221969
已完成
3 期
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
概览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,024
- 试验地点
- 217
- 主要终点
- Change in glycated haemoglobin (HbA1c)
概览
简要总结
This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.
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
- None
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.
- •Diagnosed with type 2 diabetes ≥ 180 days before screening.
- •Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
- •HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- •Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- •Renal impairment with estimated Glomerular Filtration Rate \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye 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
CagriSema
Experimental
Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.
干预措施: Cagrilintide (Drug)
CagriSema
Experimental
Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.
干预措施: Semaglutide (Drug)
Tirzepatide
Active Comparator
Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change in glycated haemoglobin (HbA1c)
时间窗: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%)-points.
Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
次要结局
- Change in HbA1c(From baseline (week 0) to end of treatment (week 68))
- Achievement of ≥ 15 % weight reduction(From baseline (week 0) to end of treatment (week 68))
- Change in systolic blood pressure(From baseline (week 0) to end of treatment (week 68))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to end of treatment (week 68))
- Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])(At end of treatment (week 68))
- Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)(From baseline (week 0) to end of treatment (week 68))
- Achievement of greater than or equal to (≥) 5% weight reduction(From baseline (week 0) to end of treatment (week 68))
- Change in diastolic blood pressure(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter)(From baseline (week 0) to end of study (week 74))
- Ratio to baseline in lipids: non-HDL cholesterol(From baseline (week 0) to end of treatment (week 68))
- Achievement of ≥ 10% weight reduction(From baseline (week 0) to end of treatment (week 68))
- Achievement of ≥ 20 % weight reduction(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Total cholesterol(From baseline (week 0) to end of treatment (week 68))
- Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Triglycerides(From baseline (week 0) to end of treatment (week 68))
- Number of Treatment-emergent Adverse Events (TEAEs)(From baseline (week 0) to end of study (week 74))
- Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3(From baseline (week 0) to end of treatment (week 68))
- Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold(From baseline (week 0) to end of study (week 74))
研究者
研究点 (217)
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