A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease. (Elevate-CKD)

AstraZeneca

Status and phase: Begins enrollment this month; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo; Drug: Elecoglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT07753993

D7265C00001

2025-523994-41-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.

Enrollment: 7,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges.
• On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.

Exclusion criteria

• BMI <23 kg/m² at screening
• History of type 1 diabetes mellitus
• HbA1c ≥10% (86 mmol/mol) at screening
• Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
• Have had more than one episode of severe hypoglycemia within 180 days prior to screening, or hypoglycemia unawareness
• Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening
• Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
• History of acute or chronic pancreatitis
• History/family history (first degree) of medullary thyroid cancer or MEN2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,000 participants in 2 patient groups

Elecoglipron

Experimental group

Description:

Elecoglipron tablet once daily

Treatment:

Drug: Elecoglipron

Placebo

Active Comparator group

Description:

Placebo matching Elecoglipron tablet once daily

Treatment:

Drug: Placebo