SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

NCT ID: NCT04889183

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2024-05-28

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, 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.

Conditions

Obesity; Albuminuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will receive a matching placebo sc. once weekly during the treatment period of 24 weeks.

Interventions

Semaglutide

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.

Intervention Type: DRUG

Placebo

Patients will receive a matching placebo sc. once weekly during the treatment period of 24 weeks.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Calgary

Calgary, Alberta, Canada

Division of Nephrology University Health Network, University of Toronto

Toronto, Ontario, Canada

University Hospital Erlangen

Erlangen, , Germany

University Hospital Wuerzburg

Würzburg, , Germany

Rijnstate

Arnhem, Gelderland, Netherlands

Isala

Zwolle, Overijssel, Netherlands

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Martini Ziekenhuis

Groningen, Provincie Groningen, Netherlands

Dept Internal Medicine, division of Nephrology Hospital Group Twente

Almelo, , Netherlands

Vall d'Hebron University Hospital

Barcelona, , Spain

Hospital Universitari de Bellvitge

Barcelona, , Spain

Hospital Da Costa Burela

Lugo, , Spain

Hospital Clínico Universitario

Valencia, , Spain

Countries

Canada; Germany; Netherlands; Spain

References

Apperloo EM, Gorriz JL, Soler MJ, Cigarran Guldris S, Cruzado JM, Puchades MJ, Lopez-Martinez M, Waanders F, Laverman GD, van der Aart-van der Beek A, Hoogenberg K, van Beek AP, Verhave J, Ahmed SB, Schmieder RE, Wanner C, Cherney DZI, Jongs N, Heerspink HJL. Semaglutide in patients with overweight or obesity and chronic kidney disease without diabetes: a randomized double-blind placebo-controlled clinical trial. Nat Med. 2025 Jan;31(1):278-285. doi: 10.1038/s41591-024-03327-6. Epub 2024 Oct 25.

Reference Type: DERIVED

PMID: 39455729 (View on PubMed)

Other Identifiers

2021-001247-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

202100166

Identifier Type: -

Identifier Source: org_study_id