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-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

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