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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 to 28
Awards & highlights

SMART Trial Summary

This trial will study whether semaglutide can help improve kidney function parameters in obese or overweight individuals who are at high risk for CKD progression.

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.Check my eligibility
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.See study design
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.

SMART Trial Eligibility Criteria

Inclusion Criteria

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

SMART Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR)
Secondary outcome measures
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

SMART 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
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

University Medical Center GroningenLead Sponsor
711 Previous Clinical Trials
976,699 Total Patients Enrolled
1 Trials studying Proteinuria
10 Patients Enrolled for Proteinuria
Novo Nordisk A/SIndustry Sponsor
1,513 Previous Clinical Trials
2,414,931 Total Patients Enrolled
1 Trials studying Proteinuria
80 Patients Enrolled for Proteinuria

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other examples in which Semaglutide has been used in a medical setting?

"Currently, 58 different medical trials are underway to study Semaglutide. The majority of these Semaglutide trials are in their third phase. While the clinical trials are largely based in Loma Linda, there are a total of 3702 locations running these studies."

Answered by AI

Have there been any other similar medical studies done before this one?

"Semaglutide has been researched since 2018, when the first clinical trial was sponsored by Novo Nordisk A/S. After the first Phase 4 trial in 2018, which involved 1387 participants, Semaglutide received drug approval. As of now, there are 58 active trials for Semaglutide across 712 cities and 55 countries."

Answered by AI

What are some of the possible side effects associated with Semaglutide?

"Semaglutide was given a 3 out of 3 for safety by our team at Power. This is because Semaglutide is a Phase 3 trial, so there is both efficacy and safety data available."

Answered by AI

What is Semaglutide commonly prescribed to treat?

"Semaglutide has shown efficacy in treating weight management, reducing caloric intake, and increasing exercise."

Answered by AI

How many people have been selected to take part in this research project?

"This research is not enrolling patients at this moment in time. It was originally posted on March 14th, 2022 and was updated on October 7th, 2022. If you are interested in other studies, there are 1,000 clinical trials currently admitting obese participants and 58 studies involving Semaglutide that are still enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes
Hiddo Lambers Heerspink 2022. "SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04889183.
~32 spots leftby Apr 2025
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