SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 13
- 主要终点
- Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR)
研究概览
简要总结
Study to assess the effects of weekly subcutaneous administration of the GLP1-RA semaglutide 2.4mg on kidney function parameters in obese/overweight individuals at high risk of CKD progression.
详细描述
Glucagon Like Peptide 1 Receptor Agonist (GLP1-RA) therapies have been introduced as antidiabetic drugs. In addition, GLP1-RA therapies reduce body weight, in patients with and without diabetes, without inducing hypoglycemia. Moreover, GLP1-RA reduce albuminuria in patients with type 2 diabetes, and liraglutide and semaglutide have been shown to improve various risk markers of CKD progression in non-diabetic obese individuals. It is therefore likely that these agents delay progression of kidney function decline in high risk obese/overweight, non-diabetic individuals.
The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria. This will be tested in a 24-week randomized placebo controlled double-blind two arm parallel clinical trial with a 4 week wash-out period after 24 weeks double blind treatment to assess off drug effects.
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
- •Age ≥ 18 years
- •Body Mass index ≥ 27 kg/m2
- •Albuminuria ≥ 30 mg/g and ≤ 3500 mg/g
- •eGFR ≥ 25 ml/min/1.73m2
- •Stable renal function prior to entry into the study defined as no more than 30% eGFR change in 3 months prior to enrolment
- •Signed Informed Consent
排除标准
- •Diagnosis with type 1 or type 2 Diabetes
- •Hba1c ≥ 6.5% at screening
- •Cardiovascular disease event in 3 months prior to enrollment
- •Treatment with GLP-1 RA < 4 weeks prior to screening
- •Uncontrolled thyroid disease TSH>6.0 mIU/L or <0.4 mIU/L at screening
- •Acute pancreatitis < 180 days prior to screening
- •History or presence of chronic pancreatitis
- •Females of child-bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
研究组 & 干预措施
Semaglutide
Patients will be treated with semaglutide 3 mg/ml s.c. once weekly for 24 weeks. The starting dose of semaglutide will be 0.24 mg subcutaneous injection with increasing doses at 4, 8, 12, and 16 weeks to 0.5, 1,0, 1.7 and 2.4 mg once weekly.
干预措施: Semaglutide (Drug)
Placebo
Patients will receive a matching placebo s.c. once weekly.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR)
时间窗: Week 1 to week 24
Measured in first morning void
次要结局
- estimated glomerular filtration rate (eGFR)(Week 1 to week 24)
- Iohexol measured glomerular filtration rate (GFR)(Week 1 to week 24)
- systolic and diastolic blood pressure(Week 1 to week 24)
- urinary albumin:creatinine ratio (UACR) during wash-out(week 24 to 28)
- estimated glomerular filtration rate (eGFR) during wash-out(week 24 to 28)
- body weight(Week 1 to week 24)
- hip circumference(Week 1 to week 24)
- extracellular fluid(Week 1 to week 24)
- high sensitivity C-reactive protein (CRP)(Week 1 to week 24)