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Clinical Trials in the USA / NCT07662213
Recruiting Phase 3

A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

NCT07662213 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-07-06
Last updated
2026-09-09

Condition(s) studied

Type 2 Diabetes Mellitus

Investigational drug(s) / intervention(s)

ElecoglipronSemaglutide

Elecoglipron: Elecoglipron is administered orally once daily.

Semaglutide: Semaglutide is administered orally once daily.

Study summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

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(s) * HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) * Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors * 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 Mellitus (T1DM), 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 Gastrointestinal (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 (NYHA IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Primary outcome measure(s)

Trial sites (209)

FacilityCityRegionStatus
Research Site Birmingham Alabama Not Yet Recruiting
Research Site Mesa Arizona Not Yet Recruiting
Research Site Phoenix Arizona Not Yet Recruiting
Research Site Tempe Arizona Not Yet Recruiting
Research Site Covina California Not Yet Recruiting
Research Site Encinitas California Not Yet Recruiting
Research Site Garden Grove California Not Yet Recruiting
Research Site Loma Linda California Not Yet Recruiting
Research Site Long Beach California Not Yet Recruiting
Research Site Pomona California Not Yet Recruiting
Research Site Sacramento California Not Yet Recruiting
Research Site Bridgeport Connecticut Not Yet Recruiting
Research Site Crystal River Florida Not Yet Recruiting
Research Site Hollywood Florida Not Yet Recruiting
Research Site Jacksonville Florida Not Yet Recruiting
Research Site Lake City Florida Not Yet Recruiting
Research Site Leesburg Florida Not Yet Recruiting
Research Site Orlando Florida Not Yet Recruiting
Research Site Lilburn Georgia Not Yet Recruiting
Research Site Idaho Falls Idaho Not Yet Recruiting
Research Site Melrose Park Illinois Not Yet Recruiting
Research Site Evansville Indiana Not Yet Recruiting
Research Site Ames Iowa Not Yet Recruiting
Research Site Wichita Kansas Not Yet Recruiting
Research Site Bowling Green Kentucky Not Yet Recruiting
Research Site Rockville Maryland Not Yet Recruiting
Research Site Southfield Michigan Not Yet Recruiting
Research Site Minneapolis Minnesota Not Yet Recruiting
Research Site Jefferson City Missouri Not Yet Recruiting
Research Site Kansas City Missouri Not Yet Recruiting
Research Site Omaha Nebraska Not Yet Recruiting
Research Site Henderson Nevada Not Yet Recruiting
Research Site Las Vegas Nevada Not Yet Recruiting
Research Site Albuquerque New Mexico Not Yet Recruiting
Research Site Durham North Carolina Not Yet Recruiting
Research Site Morehead City North Carolina Not Yet Recruiting
Research Site Raleigh North Carolina Not Yet Recruiting
Research Site Statesville North Carolina Not Yet Recruiting
Research Site Wilmington North Carolina Not Yet Recruiting
Research Site Columbus Ohio Not Yet Recruiting

+ 169 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

More AstraZeneca trials in the USA

Other trials for the same condition

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 NCT07662213 on ClinicalTrials.gov ↗ ← All trials in the USA