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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

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Chronic Kidney Disease

Interventions: Elecoglipron, Placebo

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

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 (715)
  • Huntsville, Alabama, United States
  • Montgomery, Alabama, United States
  • Sheffield, Alabama, United States
  • Peoria, Arizona, United States
  • Phoenix, Arizona, United States
  • Surprise, Arizona, United States
  • Little Rock, Arkansas, United States
  • Chula Vista, California, United States
  • Concord, California, United States
  • Daly City, California, United States
  • Fremont, California, United States
  • Huntington Beach, California, United States
  • Huntington Park, California, United States
  • Lomita, California, United States
  • National City, California, United States
  • Northridge, California, United States
  • Northridge, California, United States
  • Rolling Hills Estates, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • San Mateo, California, United States
  • Tarzana, California, United States
  • Arvada, Colorado, United States
  • Denver, Colorado, United States
  • Hartford, Connecticut, United States
  • Middlebury, Connecticut, United States
  • Waterbury, Connecticut, United States
  • Boca Raton, Florida, United States
  • Boynton Beach, Florida, United States
  • Cutler Bay, Florida, United States
  • + 685 more on CT.gov