SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

University Medical Center Groningen125 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

125

Conditions

Obesity Albuminuria

Interventions

SemaglutideDRUG

Patients will be treated for 24 weeks with semaglutide 3.0 mlg/ml s.c. once weekly. The starting dose of semaglutide will be 0.24 mg per week subcutaneous injection with increasing doses at 4, 8, 12, and 16 weeks to 0.5, 1,0, 1.7 and 2.4 mg.

PlaceboDRUG

Patients will receive a matching placebo sc. once weekly during the treatment period of 24 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (13)

University of Calgary

Calgary, Alberta, Canada

Division of Nephrology University Health Network, University of Toronto

Toronto, Ontario, Canada

University Hospital Erlangen

Erlangen, Germany

Outcomes

Primary Outcomes

Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR)

Measured in first morning void

Time frame: Week 1 to week 24

Secondary Outcomes

estimated glomerular filtration rate (eGFR)

Change from baseline to week 24 in estimated glomerular filtration rate (eGFR)

Time frame: Week 1 to week 24

Iohexol measured glomerular filtration rate (GFR)

Change from baseline to week 24 in Iohexol measured glomerular filtration rate (GFR)

Time frame: Week 1 to week 24

urinary albumin:creatinine ratio (UACR) during wash-out

Change in urinary albumin:creatinine ratio (UACR) during wash-out

Time frame: week 24 to 28

estimated glomerular filtration rate (eGFR) during wash-out

Change in estimated glomerular filtration rate (eGFR) during wash-out

Time frame: week 24 to 28

body weight

Change from baseline to week 24 in body weight

Time frame: Week 1 to week 24

hip circumference

Change from baseline to week 24 in hip circumference

Time frame: Week 1 to week 24

systolic and diastolic blood pressure

Change from baseline to week 24 in systolic and diastolic blood pressure

Time frame: Week 1 to week 24

Data from ClinicalTrials.gov

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