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Clinical Trials in India / NCT07662109
Recruiting Phase 3

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

NCT07662109 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-07-06
Last updated
2026-08-31

Condition(s) studied

Type 2 Diabetes Mellitus

Investigational drug(s) / intervention(s)

ElecoglipronDapagliflozinElecoglipron-matched placeboDapagliflozin-matched placebo

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (272)

FacilityCityRegionStatus
Research Site Huntsville Alabama Not Yet Recruiting
Research Site Mobile Alabama Not Yet Recruiting
Research Site Sheffield Alabama Not Yet Recruiting
Research Site Little Rock Arkansas Not Yet Recruiting
Research Site Bakersfield California Not Yet Recruiting
Research Site Los Angeles California Not Yet Recruiting
Research Site Ontario California Not Yet Recruiting
Research Site Lake City Florida Not Yet Recruiting
Research Site Lakeland Florida Not Yet Recruiting
Research Site Atlanta Georgia Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Skokie Illinois Not Yet Recruiting
Research Site Evansville Indiana Not Yet Recruiting
Research Site Sioux City Iowa Not Yet Recruiting
Research Site Zachary Louisiana Not Yet Recruiting
Research Site Annapolis Maryland Not Yet Recruiting
Research Site Lutherville-Timonium Maryland Not Yet Recruiting
Research Site Oxon Hill Maryland Not Yet Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Troy Michigan Not Yet Recruiting
Research Site Ridgeland Mississippi Not Yet Recruiting
Research Site Elkhorn Nebraska Not Yet Recruiting
Research Site Albuquerque New Mexico Not Yet Recruiting
Research Site Brooklyn New York Not Yet Recruiting
Research Site Raleigh North Carolina Not Yet Recruiting
Research Site Beachwood Ohio Not Yet Recruiting
Research Site Maumee Ohio Not Yet Recruiting
Research Site Norman Oklahoma Not Yet Recruiting
Research Site Kingsport Tennessee Not Yet Recruiting
Research Site Nashville Tennessee Not Yet Recruiting
Research Site Dallas Texas Not Yet Recruiting
Research Site McKinney Texas Not Yet Recruiting
Research Site Paris Texas Not Yet Recruiting
Research Site San Antonio Texas Not Yet Recruiting
Research Site South Jordan Utah Withdrawn
Research Site Arlington Virginia Not Yet Recruiting
Research Site Newport News Virginia Not Yet Recruiting
Research Site Redmond Washington Not Yet Recruiting
Research Site Kingwood West Virginia Not Yet Recruiting

+ 232 more sites — see the full list on the official registry below.

On this site

📄 Farxiga (dapagliflozin) drug profile →

More AstraZeneca trials in India

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07662109 on ClinicalTrials.gov ↗ ← All trials in India