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A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.

NCT07753993

Not Yet RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Chronic Kidney Disease

Interventions: Elecoglipron, Placebo

Countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (426)
  • Sheffield, Alabama, United States
  • Surprise, Arizona, United States
  • Chula Vista, California, United States
  • Waterbury, Connecticut, United States
  • Chicago, Illinois, United States
  • Topeka, Kansas, United States
  • Beltsville, Maryland, United States
  • Boston, Massachusetts, United States
  • Troy, Michigan, United States
  • Edina, Minnesota, United States
  • Saint Paul, Minnesota, United States
  • Eatontown, New Jersey, United States
  • Albany, New York, United States
  • Buffalo, New York, United States
  • Mineola, New York, United States
  • Morehead City, North Carolina, United States
  • Shelby, North Carolina, United States
  • Statesville, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Maumee, Ohio, United States
  • Rapid City, South Dakota, United States
  • Knoxville, Tennessee, United States
  • Morristown, Tennessee, United States
  • Arlington, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Lubbock, Texas, United States
  • Mesquite, Texas, United States
  • San Antonio, Texas, United States
  • + 396 more on CT.gov