Elecoglipron for Chronic Kidney Disease
(Elevate-CKD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called elecoglipron to determine its effectiveness for people with chronic kidney disease (CKD), with or without type 2 diabetes. The study compares elecoglipron to a placebo, which resembles the real treatment but lacks the active medicine. It targets individuals with CKD who are already on medication for it and can manage their current treatment well. Participants should not have type 1 diabetes, certain diabetes-related eye conditions, or recent serious heart issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that elecoglipron is likely to be safe for humans?
Studies have shown that elecoglipron is generally well-tolerated by patients. Research indicates that while some people may experience mild stomach issues, the treatment is considered safe for those with chronic kidney disease (CKD). Earlier studies did not report any serious side effects specifically for kidney disease patients. This suggests that elecoglipron can be a safe option for individuals with mild to moderate CKD. The current phase of trials focuses on confirming both the safety and effectiveness of elecoglipron for people with CKD.12345
Why do researchers think this study treatment might be promising?
Elecoglipron is unique because it offers a new approach to treating chronic kidney disease by potentially targeting different pathways than standard treatments like ACE inhibitors or ARBs, which primarily focus on blood pressure control and reducing proteinuria. Researchers are excited about Elecoglipron due to its novel mechanism of action, which may directly impact kidney function and slow down disease progression. This could provide a significant advantage, offering patients an alternative that might work even if other treatments are less effective.
What evidence suggests that elecoglipron might be an effective treatment for chronic kidney disease?
Research has shown that elecoglipron might help treat chronic kidney disease (CKD). Studies have found that this treatment can slow kidney damage, specifically by lowering the risk of protein leaking into urine and reducing the chance of major kidney function decline. Participants who took elecoglipron also lost weight, which can benefit kidney health. These findings suggest that elecoglipron could be a promising option for people with CKD. Participants in this trial will receive either elecoglipron or a placebo to further evaluate its effectiveness.12356
Are You a Good Fit for This Trial?
This trial is for adults with chronic kidney disease, whether or not they have type 2 diabetes. Participants must already be taking an SGLT2 inhibitor (like dapagliflozin) and other standard treatments for kidney disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either elecoglipron or placebo once daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elecoglipron
Trial Overview
The study compares a new drug called elecoglipron to a placebo. Participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting, alongside their usual CKD medications.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Elecoglipron tablet once daily
Placebo matching Elecoglipron tablet once daily
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
NCT07753993 | A Study to Investigate Outcomes With ...
A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease. 50% sustained ...
2.
clinicaltrials.eu
clinicaltrials.eu/trial/randomized-phase-iii-trial-of-elecoglipron-plus-dapagliflozin-on-kidney-outcomes-and-mortality-in-adults-with-chronic-kidney-disease/Randomized Phase III trial of elecoglipron plus ...
The study looks at adults with Chronic kidney disease (CKD), a condition where the kidneys gradually lose their ability to filter waste.
A Study to Investigate Outcomes With Elecoglipron ...
This study is testing a new medicine, elecoglipron, for chronic kidney disease. · It aims to see if elecoglipron is better than a dummy pill (placebo) when added ...
4.
astrazeneca.com
astrazeneca.com/media-centre/press-releases/2026/elecoglipron-an-oral-small-molecule-glp-1-ra-moves-to-phase-iii-programme.htmlElecoglipron, an oral small molecule GLP-1 RA, moves to ...
Weight loss in participants receiving elecoglipron did not plateau, reaching 11.8% at 36 weeks (75mg) versus 0.3% with placebo.
A Phase III study to investigate the efficacy and safety of ...
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 ...
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