SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

Phase 3

Completed

• Conditions: Obesity; Albuminuria
• Interventions: Drug: Semaglutide; Drug: Placebo

• Registration Number: NCT04889183
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Study Start: 2022-03-14
• Primary Completion: 2024-05-28
• Study Completion: 2024-05-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide	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.
Placebo	Placebo	Patients will receive a matching placebo s.c. once weekly.

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR)	Week 1 to week 24	Measured in first morning void

Secondary Outcome Measures

Name	Time	Method
estimated glomerular filtration rate (eGFR)	Week 1 to week 24	Change from baseline to week 24 in estimated glomerular filtration rate (eGFR)
Iohexol measured glomerular filtration rate (GFR)	Week 1 to week 24	Change from baseline to week 24 in Iohexol measured glomerular filtration rate (GFR)
systolic and diastolic blood pressure	Week 1 to week 24	Change from baseline to week 24 in systolic and diastolic blood pressure
urinary albumin:creatinine ratio (UACR) during wash-out	week 24 to 28	Change in urinary albumin:creatinine ratio (UACR) during wash-out
estimated glomerular filtration rate (eGFR) during wash-out	week 24 to 28	Change in estimated glomerular filtration rate (eGFR) during wash-out
body weight	Week 1 to week 24	Change from baseline to week 24 in body weight
hip circumference	Week 1 to week 24	Change from baseline to week 24 in hip circumference
extracellular fluid	Week 1 to week 24	Change from baseline to week 24 in extracellular fluid as measured by bio-impedance
high sensitivity C-reactive protein (CRP)	Week 1 to week 24	Change from baseline to week 24 in high sensitivity C-reactive protein (CRP)

Trial Locations

Locations (13)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Isala; 🇳🇱 Zwolle, Overijssel, Netherlands

University Hospital Wuerzburg; 🇩🇪 Würzburg, Germany

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Dept Internal Medicine, division of Nephrology Hospital Group Twente; 🇳🇱 Almelo, Netherlands

Hospital Clínico Universitario; 🇪🇸 Valencia, Spain

Hospital Da Costa Burela; 🇪🇸 Lugo, Spain

Division of Nephrology University Health Network, University of Toronto; 🇨🇦 Toronto, Ontario, Canada

University Hospital Erlangen; 🇩🇪 Erlangen, Germany

Martini Ziekenhuis; 🇳🇱 Groningen, Netherlands

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

Rijnstate; 🇳🇱 Arnhem, Gelderland, Netherlands