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GLP1-RA

Semaglutide for Proteinuria in Obese Individuals (SMART Trial)

Phase 3
Waitlist Available
Research Sponsored by University Medical Center Groningen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Be older than 18 years old
Must not have
Diagnosis with type 1 or type 2 Diabetes
Acute pancreatitis < 180 days prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 to 28
Awards & highlights

Summary

This trial tests if regular injections of semaglutide can help protect the kidneys in obese or overweight people at high risk of kidney disease by lowering a harmful protein in their urine. Semaglutide has shown effectiveness in weight loss and managing blood sugar levels in individuals with type 2 diabetes and obesity.

Who is the study for?
This trial is for overweight adults (BMI ≥ 27 kg/m2) with stable kidney function and a specific level of protein in their urine, indicating risk of kidney disease. It's not for those who've had recent pancreatitis, cardiovascular events, uncontrolled thyroid issues, or diabetes. Pregnant women or those planning pregnancy without proper contraception are also excluded.
What is being tested?
The study tests the effects of Semaglutide—a drug given by weekly shots—on kidney function in obese individuals without diabetes. Participants will either receive Semaglutide or a placebo to compare outcomes on albuminuria, which is an excess protein level in urine that can indicate kidney damage.
What are the potential side effects?
While the document doesn't list side effects specifically for this trial, common side effects of Semaglutide may include nausea, vomiting, diarrhea, abdominal pain and constipation. There could also be risks related to injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with diabetes.
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I have not had acute pancreatitis in the last 6 months.
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I am not pregnant, breastfeeding, planning to become pregnant, or failing to use birth control.
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I have a history of chronic pancreatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 to 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 to 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR)
Secondary study objectives
Iohexol measured glomerular filtration rate (GFR)
body weight
estimated glomerular filtration rate (eGFR)
+6 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
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 II: PlaceboPlacebo Group1 Intervention
Patients will receive a matching placebo s.c. once weekly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
GLP-1 receptor agonists, such as semaglutide, enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which can improve glycemic control and potentially reduce kidney damage. This is important for proteinuria patients because better glycemic control can reduce the progression of kidney disease. Additionally, ACE inhibitors and ARBs lower blood pressure and reduce protein excretion by dilating blood vessels and decreasing the pressure in the kidneys. These mechanisms are crucial for proteinuria patients as they help to protect kidney function and slow the progression of chronic kidney disease.

Find a Location

Who is running the clinical trial?

University Medical Center GroningenLead Sponsor
740 Previous Clinical Trials
1,028,439 Total Patients Enrolled
2 Trials studying Proteinuria
30 Patients Enrolled for Proteinuria
Novo Nordisk A/SIndustry Sponsor
1,541 Previous Clinical Trials
2,440,945 Total Patients Enrolled
1 Trials studying Proteinuria
80 Patients Enrolled for Proteinuria
~36 spots leftby Sep 2025
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