NCT05394519已完成3 期
Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 336
- 主要终点
- Achievement of greater than or equal to (≥) 5% weight reduction
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 planning to get pregnant during the study period.
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
- •Age above or equal to 18 years at the time of signing informed consent
- •BMI greather than or equal to 27.0 kg/m^2
- •Diagnosed with type 2 diabetes mellitus greater than or equal to 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 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 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) below 30 mL/min/1.73 m^2, 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
CagriSema
Experimental
Cagrilintide + semaglutide once weekly
干预措施: Cagrilintide (Drug)
CagriSema
Experimental
Cagrilintide + semaglutide once weekly
干预措施: Semaglutide (Drug)
Placebo
Placebo Comparator
Placebo cagrilintide + semaglutide once weekly
干预措施: Placebo cagrilintide (Drug)
Placebo
Placebo Comparator
Placebo cagrilintide + semaglutide once weekly
干预措施: Placebo semaglutide (Drug)
结局指标
主要结局
Achievement of greater than or equal to (≥) 5% weight reduction
时间窗: From baseline (week 0) to end of treatment (week 68)
Count of participant.
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 waist circumference(From baseline (week 0) to end of treatment (week 68))
- Change in Glycated Haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 68))
- Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in fasting serum insulin(From baseline (week 0) to end of treatment (week 68))
- Change in Diastolic Blood Pressure (DBP)(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))
- Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40)(From baseline (week 0) to end of treatment (week 68))
- Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score(From baseline (week 0) to end of treatment (week 68))
- Change in IWQOL-Lite-CT Physical Function score(From baseline (week 0) to end of treatment (week 68))
- CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL)(From baseline (week 0) to end of treatment (week 68))
- Change in Systolic Blood Pressure (SBP)(From baseline (week 0) to end of treatment (week 68))
- Change in body weight(From baseline (week 0) to end of treatment (week 68))
- Change in body mass index (BMI)(From baseline (week 0) to end of treatment (week 68))
- Change in Fasting Plasma Glucose (mmol/L)(From baseline (week 0) to end of treatment (week 68))
- Change in Fasting Plasma Glucose (mg/dL)(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in C-reactive protein (CRP)(From baseline (week 0) to end of treatment (week 68))
- Relative change in body weight(From baseline (week 0) to week 20)
- Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score(From baseline (week 0) to end of treatment (week 68))
- Achievement of HbA1c less than or equal to (≤) 6.5%(At end of treatment (week 68))
- Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup(From baseline (week 0) to end of treatment (week 68))
- CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)(From baseline (week 0) to end of treatment (week 68))
- CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL)(From baseline (week 0) to end of treatment (week 68))
- CGM: Within-day glycaemic variability (% CV)(At end of treatment (week 68))
- Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)(From baseline (week 0) to end of study (week 75))
- 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 75))
- CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides and Free fatty acids(From baseline (week 0) to end of treatment (week 68))
- Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score(From baseline (week 0) to end of treatment (week 68))
- Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score(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 75))
- Change in Control of Eating Questionnaire (CoEQ): Craving Control score, Positive Mood score, Craving for Sweet score, Craving for Savoury food score, Hunger score and Satiety score(From baseline (week 0) to end of treatment (week 68))
- Continuous glucose monitoring: Change in mean glucose (mmol/L)(From baseline (week 0) to end of treatment (week 68))
- Continuous glucose monitoring: Change in mean glucose (mg/L)(From baseline (week 0) to end of treatment (week 68))
- Number of Treatment Emergent Serious adverse events (TESAEs)(From baseline (week 0) to end of study (week 75))
研究者
研究点 (336)
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