7000 Participants NeededMy employer runs this trial

Elecoglipron for Chronic Kidney Disease

(Elevate-CKD Trial)

Recruiting at 540 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: ACEI, ARB, SGLT2i
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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

I have been taking a stable dose of ACEI or ARB for at least 4 weeks.
I am an adult with chronic kidney disease and lab results showing reduced kidney function.

Exclusion Criteria

I have had pancreatitis in the past.
BMI <23 kg/m² at screening
HbA1c ≥10% (86 mmol/mol) at screening
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elecoglipron or placebo once daily

Up to 4.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: ElecoglipronExperimental Treatment1 Intervention
Group II: PlaceboActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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 ...

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 ...

Elecoglipron, 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 ...

Top Chronic Kidney Disease Clinical Trials | Power

The drug already has data showing both safety and effectiveness. Elecoglipron for Chronic Kidney Disease to the Power online platform.