What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as semaglutide, are commonly used to manage conditions like proteinuria by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying. Known side effects of these treatments include gastrointestinal issues such as nausea, vomiting, and diarrhea. Additionally, there is a potential risk of thyroid C-cell tumors, as observed in rodent studies, although this risk has not been confirmed in humans. Other side effects may include decreased appetite and weight loss. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia should avoid these medications.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of type 2 diabetes, which have shown benefits in glycemic control and cardiovascular outcomes. These include liraglutide, exenatide, dulaglutide, and semaglutide. While these drugs are primarily approved for diabetes management, they have also demonstrated potential benefits in reducing proteinuria and improving kidney outcomes in patients with diabetes. For instance, liraglutide and semaglutide have shown favorable effects on kidney function parameters in clinical trials, suggesting their potential utility in managing proteinuria.

What other types of research exist?

Promising alternatives to Semaglutide for proteinuria patients include other GLP-1 receptor agonists such as Liraglutide and Dulaglutide. Both have demonstrated benefits in glycemic control and renal outcomes. Additionally, Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors like Dapagliflozin and Empagliflozin are also promising due to their positive effects on kidney function and cardiovascular outcomes.

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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

Pivotal Trial

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

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with diabetes.

Select...

I have not had acute pancreatitis in the last 6 months.

Select...

I am not pregnant, breastfeeding, planning to become pregnant, or failing to use birth control.

Select...

I have a history of chronic pancreatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 to 28

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%

Study treatment Arm

Overall Study

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 5Eligibility criteria met

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.