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A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus

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

ClinicalTrials.gov IDNCT07662044

PhasePHASE3

Enrollment800

SponsorAstraZeneca

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes Mellitus

About this study

Interventions

Drug: Elecoglipron — Elecoglipron is administered orally once daily.
Drug: Dapagliflozin — Dapagliflozin administered orally once daily.
Drug: Elecoglipron-matched placebo — A placebo matching elecoglipron, administered orally once daily.
Drug: Dapagliflozin-matched placebo — A placebo matching dapagliflozin, administered orally once daily.

Primary outcomes

Change from baseline in Hemoglobin A1c (HbA1c) (Baseline to Week 40)

Eligibility information

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 locations

Research Site, Birmingham, Alabama 35233 United States
Research Site, Daphne, Alabama 36526 United States
Research Site, Lomita, California 90717 United States
Research Site, Los Alamitos, California 90720 United States
Research Site, San Diego, California 92111 United States
Research Site, Walnut Creek, California 94598 United States
Research Site, Englewood, Colorado 80110 United States
Research Site, Bridgeport, Connecticut 06606 United States
Research Site, Jacksonville, Florida 32256 United States
Research Site, Orlando, Florida 32801 United States

Showing 10 of 149 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-09.