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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) (Eluminate-3)

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Placebo in Adults with Type 2 Diabetes Mellitus on
Background Insulin (Eluminate-3)

Tsugumi Hirotaka

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Tsugumi Hirotaka

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

+81-6-4802-3600

RD-clinical-information-Japan@astrazeneca.com

Recruiting

June. 30, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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 or more 7% to or less 10.5%

- Body mass index (BMI) of or more 23 kg/m2 at screening

- Stable body weight (self-reported or documented) for 90 days prior to screening

- 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

Both

Type 2 Diabetes Mellitus

Drug - Elecoglipron dose level 1: Elecoglipron is administered orally once daily.

Drug - Elecoglipron dose level 2: Elecoglipron is administered orally once daily.

Drug - Placebo: Placebo is administered orally once daily.

Change from baseline in Hemoglobin A1c (HbA1c)
[Time Frame: Baseline to Week 40]

+81-29-353-2800

May. 21, 2026

Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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