Trial to study the effect of semaglutide on reducing urinary albumin excretion in people with serious overweight without diabetes.

Phase 1

• Conditions: Overweight and obese individuals at high risk of chronic kidney disease progression.; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10001580Term: AlbuminuriaSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-001247-27-DE
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-27
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: Assess the effect of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) on:<br>-eGFR (all patients)<br>-Iohexol measured GFR (46 patients), <br>-change in UACR and eGFR during wash-out from week 24 to 28<br>-body weight and hip circumference<br>-systolic/diastolic blood pressure<br>-extracellular fluid using bio-impedance spectroscopy (Impedimed FP7)<br>-high sensitivity CRP.<br>;Primary end point(s): Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR).;Timepoint(s) of evaluation of this end point: Change from baseline to week 24, ie from just before start of treatment untill the end of the treatment period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes from baseline to week 24 in the following parameters: <br>•eGFR (all subjects)<br>•Iohexol measured GFR (46 subjects)<br>•Change in UACR and eGFR during wash-out from week 24 to 28<br>•Body weight and hip circumference<br>•Systolic/diastolic blood pressure<br>•Extracellular fluid using bio-impedance spectroscopy (Impedimed FP7)<br>•High sensitivity CRP;Timepoint(s) of evaluation of this end point: Change from baseline to week 24, ie from just before start of treatment untill the end of the treatment period.