CTRI/2024/11/076345进行中（未招募）2 期
Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema 2.4 mg or 2.4 mg) once weekly versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo in people with chronic kidney disease and type 2 diabetes living with overweight or obesity
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 618
- 试验地点
- 7
- 主要终点
- To investigate whether CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and
研究概览
简要总结
CagriSema is currently under development by Novo Nordisk for indications within weight management, T2D, and cardiovascular disease, and is further being considered for the development in heart failure with preserved ejection fraction (HFpEF), nonalcoholic steatohepatitis (NASH), and alcoholic liver disease (ALD).
The proposed study is in accordance with the regulatory guidelines for developing fixed dose combination medicinal products to show the contribution of each monocomponent to the claimed effects within a new indication. To support this, the study tests CagriSema 2.4 mg/2.4 mg as well as the individual contribution from semaglutide 2.4 mg and cagrilintide 2.4 mg to placebo to substantiate effects of both monocomponents for the treatment of chronic kidney disease in people
with T2D, CKD and overweight or obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Male or female.
- •Age 18 years or above at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus less than or equal to 180 days before screening.
- •4.BMI more than or equal to 27.0 kg per m2 at screening.
- •BMI will be calculated in the eCRF based on height and body weight at screening.
- •HbA1c less than or equal to 10.5 percent (91 mmol per mol) as assessed by central laboratory at screening.
- •Kidney impairment defined by serum creatinine and cystatin C-based eGFR more than or equal to 15 and less than 90 mL per min per 1.73 m2 (CKD-EPI 2021) as assessed by central laboratory at screening.
- •Albuminuria defined by UACR more than or equal to 100 and less than 5000 mg per ga as assessed by central laboratory at screening.
- •Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator.
- •Treatment dose must be stable for at least 30 days prior to 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.
- •Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
- •Use of any GLP-1RA (including medication with GLP-1RA activity, e.g., GIP or GLP-1RA) or amylin analogue within 60 days prior to screening.
- •Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening.
- •Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before 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.
- •Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ or high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.
结局指标
主要结局
To investigate whether CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and
时间窗: From baseline | (week 0) to end of | treatment (week 26)
placebo improves surrogate markers of CKD progression in participants with T2D - Change in UACR
时间窗: From baseline | (week 0) to end of | treatment (week 26)
次要结局
- To compare the effect of CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo with respect to Weight-related parameters(From baseline)
- To compare the effect of CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo with respect to Glycaemic control(From baseline)
- To compare the effect of CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo with respect to Blood pressure(From baseline)
- to compare the effect of CagriSema 2.4 mg per 2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo with respect to Safety and tolerability(From baseline)
研究者
研究点 (7)
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