Status:
COMPLETED
SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Obesity
Albuminuria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, witho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04889183
Start Date
March 14 2022
End Date
May 28 2024
Last Update
April 22 2025
Active Locations (13)
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1
University of Calgary
Calgary, Alberta, Canada, 3230
2
Division of Nephrology University Health Network, University of Toronto
Toronto, Ontario, Canada, M5G 2C4
3
University Hospital Erlangen
Erlangen, Germany, 91054
4
University Hospital Wuerzburg
Würzburg, Germany, 97080