SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

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.

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