Coming Soon
This study will begin recruiting soon.
A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease. (Elevate-CKD)
About This Study
This Phase III study evaluates whether elecoglipron 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
- •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