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900 Participants NeededMy employer runs this trial

Elecoglipron for Diabetic Nephropathy

(Eluminate-4 Trial)

Recruiting at 155 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: SGLT2 inhibitors
Must not be taking: Gastric motility drugs
Disqualifiers: Type 1 diabetes, Pancreatitis, others
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?

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes and reduced kidney function who are already taking dapagliflozin (an SGLT2 inhibitor) and possibly other diabetes medications. Participants should not have conditions or treatments that could interfere with the study.

Inclusion Criteria

Stable body weight (self-reported or documented) for 90 days prior to screening
Body mass index (BMI) of ≥ 23 kg/m2 at screening
I have had Type 2 Diabetes for at least 90 days.
See 4 more

Exclusion Criteria

I am currently being treated for diabetic eye disease or macular swelling.
I have had multiple severe low blood sugar episodes or trouble noticing low blood sugar.
I have a serious upper digestive condition or take medicine that affects my stomach's movement.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elecoglipron or placebo orally once daily in addition to background dapagliflozin 10 mg

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares a new drug, elecoglipron, to a placebo in people with type 2 diabetes and kidney problems. All participants continue their usual dapagliflozin treatment. The goal is to see if elecoglipron helps control blood sugar safely.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Elecoglipron dose level 2Experimental Treatment1 Intervention
Group II: Elecoglipron dose level 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 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

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