A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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), treated with a background insulin and other background glucose-lowering medication(s)

Key facts

Study ID

NCT07664553

Run by

AstraZeneca

People needed

600

Starts

2026-07-08

Expected to finish

2028-05-23

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with T2DM for at least 90 days prior to screening
• Stable treatment with background insulin and other background glucose-lowering medication(s)
• HbA1c value of ≥ 7% to ≤ 10.5%
• Body mass index (BMI) of ≥ 23 kg/m2 at screening
• Stable body weight (self-reported or documented) for 90 days prior to screening

You may not qualify if…

• 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 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

Where it is running

• Research Site — Toronto, Ontario, Canada (enrolling)
• Research Site — Miyazaki, Japan (enrolling)
• Research Site — East Toowoomba, Australia (enrolling)
• Research Site — Vancouver, British Columbia, Canada (enrolling)
• Research Site — Naka, Japan (enrolling)
• Research Site — Ocoee, Florida, United States (enrolling)
• Research Site — Decatur, Georgia, United States
• Research Site — Myrtle Beach, South Carolina, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Morehead City, North Carolina, United States
• Research Site — Kozloduy, Bulgaria
• Research Site — Memphis, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Round Rock, Texas, United States
• Research Site — Cary, North Carolina, United States
• Research Site — Doral, Florida, United States
• Research Site — Campbelltown, Australia
• Research Site — Brooklyn, New York, United States
• Research Site — Heidelberg Heights, Australia
• Research Site — Parkville, Australia
• Research Site — St Leonards, Australia
• Research Site — Dupnitsa, Bulgaria
• Research Site — Renton, Washington, United States
• Research Site — Plovdiv, Bulgaria
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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