SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes (SMART)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 3

Conditions: Albuminuria; Obesity

Treatments: Drug: Semaglutide; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04889183

2021-001247-27 (EudraCT Number)

202100166

Details and patient eligibility

About

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.

Full 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, without inducing hypoglycemia. Moreover, GLP1-RA reduce albuminuria in patients with type 2 diabetes, and liraglutide and semaglutide have been shown to improve various risk markers of CKD progression in non-diabetic obese individuals. It is therefore likely that these agents delay progression of kidney function decline in high risk obese/overweight, non-diabetic individuals.

The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria. This will be tested in a 24-week randomized placebo controlled double-blind two arm parallel clinical trial with a 4 week wash-out period after 24 weeks double blind treatment to assess off drug effects.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Description:

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.

Treatment:

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

Patients will receive a matching placebo s.c. once weekly.

Treatment:

Drug: Placebo