SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

NCT04889183 | Completed Phase 3

• 2 other identifiers: 2021001662021-001247-27
• Study Type: interventional
• Target: 125
• Locations: 4 countries
• Sites: 13

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.

Conditions

Obesity; Albuminuria

Keywords

SMART; Semaglutide; UMCG; Lambers Heerspink

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR)

  Measured in first morning void

  Week 1 to week 24

Secondary Outcomes (9)

• estimated glomerular filtration rate (eGFR)

  Week 1 to week 24

• Iohexol measured glomerular filtration rate (GFR)

  Week 1 to week 24

• urinary albumin:creatinine ratio (UACR) during wash-out

  week 24 to 28

• estimated glomerular filtration rate (eGFR) during wash-out

  week 24 to 28

• body weight

  Week 1 to week 24

Study Arms (2)

Semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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.

Semaglutide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Novo Nordisk A/S: collaborator

Study Sites (13)

University of Calgary

Calgary, Alberta, 3230, Canada

Location

Division of Nephrology University Health Network, University of Toronto

Toronto, Ontario, M5G 2C4, Canada

Location

University Hospital Erlangen

Erlangen, 91054, Germany

Location

University Hospital Wuerzburg

Würzburg, 97080, Germany

Location

Rijnstate

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Isala

Zwolle, Overijssel, 8025 AB, Netherlands

Location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

Martini Ziekenhuis

Groningen, Provincie Groningen, 9728 NT, Netherlands

Location

Dept Internal Medicine, division of Nephrology Hospital Group Twente

Almelo, 7609 PP, Netherlands

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Da Costa Burela

Lugo, 27880, Spain

Location

Hospital Clínico Universitario

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 39455729 DERIVED

MeSH Terms

Conditions

Obesity; Albuminuria

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized placebo controlled double-blind two arm parallel clinical trial

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 17, 2021
• Study Start: March 14, 2022
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: April 22, 2025

Record last verified: 2024-11

Locations

DE (2); ES (4); CA (2); NL (5)