2024-510846-15-00招募中2 期
Efficacy, safety, and pharmacokinetics of NNC0519-0130 once weekly s.c. versus semaglutide 1.0 mg and placebo in people with chronic kidney disease, with or without type 2 diabetes, and with overweight or obesity: a proof-of-concept and dose-finding study
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 39
- 主要终点
- Change in UACR From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)
研究概览
简要总结
To demonstrate and characterise the dose-response relationship of once weekly (QW) s.c. NNC0519-0130 with respect to relative reduction in urinary albumin-to-creatinine ratio (UACR)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Female of non-childbearing potential or male.
- •Age 18 years or above at the time of signing the informed consent.
- •Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening, or not diagnosed with type 2 diabetes mellitus.
- •HbA1c of 6.5% -10.5% [48 – 91 mmol/mol] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of <6.5% [<48 mmol/mol] if not diagnosed with type 2 diabetes mellitus.
- •BMI ≥ 27.0 kg/m2 at screening.
- •Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 mL/min/1.73 m
- •Albuminuria defined by UACR ≥ 100 and < 5000 mg/g.
- •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 effective contraceptive method.
- •Polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis. Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to enrolment.
- •Use of any GLP-1RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening.
- •Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening.
- •Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
- •Uncontrolled and potentially unstable diabetic retinopathy or diabetic 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/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.
研究组 & 干预措施
Ozempic 0.5 mg solution for injection in pre-filled pen
Comparator
干预措施: Ozempic 0.5 mg solution for injection in pre-filled pen (Drug)
Placebo A
Placebo
干预措施: Placebo A (Drug)
NNC0519-0130
Test
干预措施: NNC0519-0130 (Drug)
结局指标
主要结局
Change in UACR From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)
Change in UACR From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)
次要结局
- Achievement of ≥ 10 % weight reduction from baseline to end of treatment
- Change in waist circumference from baseline to end of treatment
- Achievement of ≥ 5 % weight reduction from baseline to end of treatment
- Change in glycated haemoglobin (HbA1c) from baseline to end of a given maintenance dose period (week 12, 24 or 36)
- Change in eGFR (creatinine and cystatin C-based CKD-EPI 2021) from baseline to end of treatment
- Change in eGFR (creatinine-based CKD-EPI 2021) from baseline to end of treatment
- Relative change in body weight from baseline to end of treatment
- Change in systolic blood pressure from baseline to end of treatment
- Change in diastolic blood pressure from baseline to end of treatment
- Number of treatment emergent adverse events (TEAEs) from baseline to end of study
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (39)
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