← Back to Search
GLP-1 Receptor Agonist
Semaglutide for Polycystic Kidney Disease
Aurora, CO
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
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
See full description
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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 65 years old.
show original
Select...
My kidney function is adequate.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes.
show original
Select...
I am currently using or plan to start using Tolvaptan.
show original
Select...
I or my family have a history of specific thyroid cancers or conditions.
show original
Select...
I have had pancreatitis before.
show original
Select...
I have been diagnosed with an eating disorder such as anorexia, bulimia, or binge eating.
show original
Select...
I have had cancer or a cancerous tumor in the last 5 years.
show original
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 months, 6-months, 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, 6-months, 12-months
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 moreOther study objectives
Adherence
Change in dietary energy Intake
Change in free-living physical activity
+6 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TirzepatideExperimental Treatment1 Intervention
To minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg/week. All dose changes will be documented in the study records.
Group II: PlaceboPlacebo Group1 Intervention
To minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg/week. All dose changes will be documented in the study records.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7510
Find a Location
Closest Location:University of Colorado - Anschutz Medical Campus· Aurora, CO
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,841 Previous Clinical Trials
3,028,456 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,504 Previous Clinical Trials
4,364,299 Total Patients Enrolled
Mayo ClinicOTHER
3,414 Previous Clinical Trials
3,209,063 Total Patients Enrolled
Washington University School of MedicineOTHER
2,022 Previous Clinical Trials
2,352,118 Total Patients Enrolled