Recruiting
Phase 3

Elecoglipron

Sponsor:

AstraZeneca

Code:

NCT07662135

Conditions

Type 2 Diabetes Mellitus

Type 2 Diabetes With Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elecoglipron

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

Conditions

Type 2 Diabetes Mellitus

Type 2 Diabetes With Chronic Kidney Disease

Study ID

NCT07662135

Start date

Jul 6, 2026

Status verified date

Sep, 2026

Completion date

Jul 13, 2028

Anticipated

Primary completion date

Jul 13, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening
  • On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
  • HbA1c value:

1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
2. SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)
  • Impaired renal function
  • Body mass index (BMI) of ≥ 23 kg/m2 at screening
  • Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion Criteria:

  • Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
  • 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 has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
  • 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
  • Severe congestive heart failure (New York Heart Association IV)
  • History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elecoglipron dose level 1

Participants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg.

experimental: Elecoglipron dose level 2

Participants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg.

placebo comparator: Placebo

Participants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg.

Interventions

Elecoglipron

Elecoglipron is administered orally once daily.

Placebo

Placebo is administered orally once daily.

Primary outcome measure

  • Change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 40 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Sacramento, California, United States, 95821

Research Site

Recruiting

Miami Lakes, Florida, United States, 33016

Research Site

Recruiting

Ocoee, Florida, United States, 34761

Research Site

Recruiting

Kansas City, Missouri, United States, 64112

Research Site

Recruiting

Albuquerque, New Mexico, United States, 87102

Research Site

Recruiting

Raleigh, North Carolina, United States, 27609

Research Site

Recruiting

Gaffney, South Carolina, United States, 29340

More Information

Sponsor

AstraZeneca

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-02.