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SeMaglutide and Albuminuria Reduction Trial in obese individuals without diabetes

SeMaglutide and Albuminuria Reduction Trial in obese individuals without diabetes - SMART

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50899
Enrollment
40
Registered
2021-06-09
Start date
2022-03-14
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and chronic kidney disease

Interventions

Eligible participants will be randomly assigned to 24 weeks treatment with either semaglutide s.c. 2.4 mg once weekly (Semaglutide 3 mg/ml) or placebo. The starting dose of semaglutide will be 0.24

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >= 18 years • Body Mass index >= 27 kg/m2 • Albuminuria >= 30 mg/g and = 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

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 6.0 mIU/L or

Design outcomes

Primary

MeasureTime frame
Change from baseline to week 24 in first morning void urinary albumin:creatinine ratio (UACR).

Secondary

MeasureTime frame
Change from baseline in: - eGFR (all subjects), - Iohexol measured GFR (46 subjects), - change in UACR and eGFR during wash-out from week 24 to 28, - body weight - hip circumference, - systolic/diastolic blood pressure, - extracellular fluid, - high sensitivity CRP.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)