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GLP-1 Receptor Agonist

Weight Management for Obesity and Kidney Disease

Phase 4

Recruiting

Led By Kristin K Clemens, MD, MSc

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

More than 10% risk of end-stage kidney disease (ESKD) requiring renal replacement therapy over 2 years or currently receiving dialysis

Be older than 18 years old

Must not have

No access to semaglutide via drug coverage

Type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial is testing a new weight management program for people with obesity and kidney disease who are trying to lose weight before a kidney transplant. Participants will be randomly assigned to either the weight management program or their

Who is the study for?

This trial is for individuals with obesity and high-risk chronic kidney disease (CKD) or those on dialysis, aiming to lose weight for a kidney transplant. Participants must be seeking to manage their weight and willing to engage in a virtual program.

What is being tested?

The OK-TRANSPLANT 2 study is testing the effectiveness of virtual weight management coaching compared to usual care practices. Additionally, it will evaluate the use of Semaglutide, a medication that may aid in weight loss.

What are the potential side effects?

Semaglutide can cause digestive issues like nausea, vomiting, diarrhea; risk of low blood sugar; possible thyroid tumors; and inflammation of the pancreas. Virtual coaching has no direct medical side effects but may vary in effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at high risk for severe kidney failure or am on dialysis.

Exclusion Criteria

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

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I do not have insurance coverage for semaglutide.

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I have Type 1 diabetes.

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I cannot have a kidney transplant due to health reasons.

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I am taking more than the starting dose of a GLP-1 receptor agonist.

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I cannot take GLP-1 receptor agonists due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recruitment Rate

Secondary study objectives

Adherence to Scheduled Coaching Visits

Adherence to Study Medication

Adverse events

+1 more

Other study objectives

Change in 2-week glycemic variability and time in range (TIR)

Change in 2-week mean fasting glucose

Percentage of Change in HbA1c

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Weight Management ProgramExperimental Treatment2 Interventions

A maximum tolerated dose of semaglutide (Ozempic/Wegovy) will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months.

Group II: Usual CareActive Control1 Intervention

Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160

0 / 6Eligibility criteria met