SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

Sponsor
University Medical Center Groningen
Study ID
NCT04889183
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Patients will be treated for 24 weeks with semaglutide 3.0 mlg/ml s.c. once weekly. The starting dose of semaglutide will be 0.24 mg per week subcutaneous injection with increasing doses at 4, 8, 12, and 16 weeks to 0.5, 1,0, 1.7 and 2.4 mg.
  • Placebo — DRUG
    Patients will receive a matching placebo sc. once weekly during the treatment period of 24 weeks.

Study Details

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.

Key Dates

Start date
Mar 14, 2022
Status verified
Nov 2024
Primary completion
May 28, 2024
Completion
May 28, 2024

Study Design

Enrollment
125 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Comparator: Placebo
    Patients will receive a matching placebo s.c. once weekly.

Primary Outcome Measure

Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR) [ Time Frame: Week 1 to week 24 ]

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