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GLP-1 Receptor Agonist

Semaglutide for Polycystic Kidney Disease

Phase 2

Waitlist Available

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

18-65 years of age

Estimated glomerular filtration rate ≥ 30 mL/min/1.73m^2

Must not have

Diabetes mellitus

Tolvaptan usage or plans to initiate tolvaptan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 months, 6-months, 12-months, 24-months

Summary

This trial will investigate if a two-year treatment with a medication used for weight management can slow down kidney growth in adults with a specific kidney disease who are overweight or obese. The study will also look at

Who is the study for?

Adults aged 18-65 with autosomal dominant polycystic kidney disease (ADPKD), overweight or obese, and a reasonable level of kidney function. Participants should not be in other weight loss programs or clinical studies and must have had a recent ultrasound or MRI.

What is being tested?

The trial is testing Semaglutide, a drug used for weight management that may slow kidney growth in ADPKD patients. It compares the effects of this drug to a placebo over two years, using advanced imaging to monitor changes.

What are the potential side effects?

Semaglutide can cause digestive issues like nausea and diarrhea, risk of low blood sugar levels, potential pancreatitis, allergic reactions, and may affect heart rate. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My kidney function is adequate.

Exclusion Criteria

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

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I have diabetes.

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I am currently using or plan to start using Tolvaptan.

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I or my family have a history of specific thyroid cancers or conditions.

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I have had pancreatitis before.

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I have been diagnosed with an eating disorder such as anorexia, bulimia, or binge eating.

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I have had cancer or a cancerous tumor in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months, 6-months, 12-months, 24-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 months, 6-months, 12-months, 24-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6-months, 12-months, 24-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

Change in height-Adjusted Total kidney volume

Secondary study objectives

Change in 8-isoprostane (circulating)

Change in 8-isoprostane (urinary)

Change in HOMA-IR

+12 more

Other study objectives

Adherence

Change in dietary energy Intake

Change in free-living physical activity

+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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention

To minimize the risk of gastrointestinal adverse events, a standard and proven dose-escalation regimen will be employed, starting at 0.25 mg once weekly semaglutide at randomization. Following 4 weeks of treatment with 0.25 mg, the dose will be escalated to 0.5 mg once weekly and maintained for another 4 weeks until finally escalating to the target dose of 1 mg once weekly semaglutide. Participants will remain on the 1 mg dose for 22 months until the end of treatment visit; however, dose reductions and extensions of dose escalation intervals will be allowed (e.g., if treatment with trial product is associated with unacceptable adverse events). The minimum tolerated dose to remain in the study is 0.50 mg/week. All dose changes will be recorded.

Group II: PlaceboPlacebo Group1 Intervention

To minimize the risk of gastrointestinal adverse events, a standard and proven dose-escalation regimen will be employed, starting at 0.25 mg once weekly placebo at randomization. Following 4 weeks of treatment with 0.25 mg, the dose will be escalated to 0.5 mg once weekly and maintained for another 4 weeks until finally escalating to the target dose of 1 mg once weekly placebo. Participants will remain on the 1 mg dose for 22 months until the end of treatment visit; however, dose reductions and extensions of dose escalation intervals will be allowed (e.g., if treatment with trial product is associated with unacceptable adverse events). The minimum tolerated dose to remain in the study is 0.50 mg/week. All dose changes will be recorded.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160

0 / 8Eligibility criteria met