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

NCT07753993Sponsor: AstraZeneca

Principal investigators

Patients can be seen at: University Hospital, Kidney Care Centre - Clinics, Victoria Hospital

Actively Recruiting

  • University Hospital teamRecruiting

  • Victoria Hospital teamRecruiting

View on ClinicalTrials.gov ↗

About This Study

This Phase III study evaluates whether elecoglipron (oral GLP-1RA) reduces renal outcomes and mortality compared with placebo in participants with CKD, with or without T2DM. Participants receive elecoglipron or placebo in a randomized, double-blind, parallel-group design. Treatment is added to background dapagliflozin and other standard-of-care CKD therapies.

Who Can Participate?

✓ Inclusion Criteria

  • •(UACR 3.39-22.6 mg/mmol with eGFR 20-40) OR (UACR > 22.6 with eGFR 20-60) OR (UACR > 56.5 with eGFR 61-90)
  • •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
  • •GLP-1 RA within 90 days of screening