SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Novo Nordisk A/S

Criteria

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