Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582875
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Advancing ADPKD Treatment with GLP-1RA a Study of Glucagon-Like Peptide-1 Receptor Agonists Efficacy Safety and Mechanism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed clinical trial aims to assess if two years of treatment with a glucagon-like peptide 1 receptor agonist a medication approved for weight management that also improves the bodys response to glucose and insulin can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques Blood and urine samples will provide further insight into biological changes that may be linked to the benefits of the intervention while ensuring careful monitoring of safety and tolerability
Detailed Description:
Autosomal dominant polycystic kidney disease ADPKD is a common inherited disorder that leads to kidney failure The only approved treatment to decelerate kidney disease progression in patients with ADPKD is tolvaptan but its usage is limited due to frequent side effects affecting adherence Thus alternative interventions that may slow ADPKD progression hold considerable clinical importance In line with the general population body-mass index and insulin resistance have been increasing in patients with ADPKD The investigators have shown that visceral adiposity associates strongly with accelerated progression of early-stage ADPKD Pilot study suggested that diet-induced weight loss may slow kidney growth in height-adjusted total kidney volume htTKV by magnetic resonance imaging and the study team is currently evaluating the efficacy of daily caloric restriction-induced weight loss for slowing ADPKD progression in a phase IIa clinical trial However the long-term adherence to lifestyle interventions is challenging making pharmacological interventions a compelling adjunct or alternative Moreover the study team recently demonstrated that adults with ADPKD and preserved kidney function exhibited insulin resistance via the gold-standard hyperinsulinemic-euglycemic clamps and impaired kidney oxidative metabolism via 11C-acetate PET which were strongly associated with htTKV These novel data suggest that targeting improvements in insulin sensitivity and kidney oxidative metabolism in addition to weight loss may slow ADPKD progression Glucagon-like peptide 1 receptor agonists GLP-1RAs were recently FDA-approved for the treatment of obesity and show promise in substantially reducing adiposity and improving insulin sensitivity Additionally evidence indicates that GLP-1RAs may transform CKD management by reducing kidney events in patients with and without diabetes via effects extending beyond glycemic modulation and in part via attenuated kidney inflammation and oxidative stress However GLP-1RAs have not yet been evaluated as a novel therapy for slowing ADPKD progression in patients with overweightobesity Thus the current study is a 24-month phase II randomized placebo-controlled double-blind clinical trial using a GLP-1RA in 126 adults with ADPKD and overweight or obesity to slow kidney growth primary outcome The trial will also evaluate changes in total body weight adipose volume and function insulin resistance kidney oxidative metabolism and inflammation and carefully monitor safety and tolerability As a novel therapeutic in ADPKD GLP-1RAs could transform the treatment landscape for patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None