A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
Purpose
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.
Condition
- Chronic Kidney Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Placebo controlled
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Elecoglipron |
Elecoglipron tablet once daily |
|
|
Active Comparator Placebo |
Placebo matching Elecoglipron tablet once daily |
|
Recruiting Locations
Research Site
Minneapolis, Minnesota 55435
Minneapolis, Minnesota 55435
Research Site
Arlington, Texas 76015
Arlington, Texas 76015
Research Site
South Salt Lake, Utah 84115
South Salt Lake, Utah 84115
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com