Recruiting

Phase 3

Elecoglipron & DapagliflozinA Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus

Sponsor:

AstraZeneca

Code:

NCT07662109

Conditions

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elecoglipron

Dapagliflozin

Elecoglipron-matched placebo

Dapagliflozin-matched placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Conditions

Type 2 Diabetes Mellitus

Study ID

NCT07662109

Start date

Jul 6, 2026

Status verified date

Oct, 2026

Completion date

Jul 5, 2028

Anticipated

Primary completion date

Jul 5, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
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

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elecoglipron dose level 1 + dapagliflozin

Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily.

experimental: Elecoglipron dose level 2 + dapagliflozin

Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily.

experimental: Elecoglipron dose level 1 + dapagliflozin-matched placebo

Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.

experimental: Elecoglipron dose level 2 + dapagliflozin-matched placebo

Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.

active comparator: Elecoglipron-matched placebo + dapagliflozin

Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily.

Interventions

Elecoglipron

Elecoglipron is administered orally once daily.

Dapagliflozin

Dapagliflozin administered orally once daily.

Elecoglipron-matched placebo

A placebo matching elecoglipron administered orally once daily.

Dapagliflozin-matched placebo

A placebo matching dapagliflozin 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

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

Locations

Research Site

Recruiting

Little Rock, Arkansas, United States, 72205

Research Site

Recruiting

Los Angeles, California, United States, 90017

Research Site

Recruiting

Lake City, Florida, United States, 32055

Research Site

Recruiting

Lakeland, Florida, United States, 33813

Research Site

Recruiting

Chicago, Illinois, United States, 60640

Research Site

Recruiting

Oxon Hill, Maryland, United States, 20745

Research Site

Recruiting

Troy, Michigan, United States, 48098

Research Site

Recruiting

Ridgeland, Mississippi, United States, 39157

Research Site

Recruiting

Albuquerque, New Mexico, United States, 87112

Research Site

Recruiting

Brooklyn, New York, United States, 11201

Research Site

Recruiting

Maumee, Ohio, United States, 43537

Research Site

Recruiting

Kingsport, Tennessee, United States, 37660

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research Site

Recruiting

Dallas, Texas, United States, 75230

Research Site

Recruiting

Paris, Texas, United States, 75462

Research Site

Recruiting

Newport News, Virginia, United States, 23606

Research Site

Recruiting

Kingwood, West Virginia, United States, 26537

More Information

Sponsor

AstraZeneca

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.