Recruiting
Phase 3

Elecoglipron

Sponsor:

AstraZeneca

Code:

NCT07753993

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elecoglipron

Placebo

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Disease

Study ID

NCT07753993

Start date

Aug 21, 2026

Status verified date

Sep, 2026

Completion date

Oct 4, 2030

Anticipated

Primary completion date

Oct 4, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

7000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elecoglipron

Elecoglipron tablet once daily

active comparator: Placebo

Placebo matching Elecoglipron tablet once daily

Interventions

Elecoglipron

Elicoglipron tablet

Placebo

Placebo tablet

Primary outcome measure

  • To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality [ Time Frame: Event-driven, trial is estimated to be up to 4.5 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Minneapolis, Minnesota, United States, 55435

Research Site

Recruiting

Arlington, Texas, United States, 76015

Research Site

Recruiting

South Salt Lake, Utah, United States, 84115

Research Site

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Research Site

Recruiting

Waterloo, Ontario, Canada, N2T 0C1

More Information

Sponsor

AstraZeneca

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Chronic kidney disease
  • Elecoglipron

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-09.