Recruiting
Phase 3

Elecoglipron

Sponsor:

AstraZeneca

Code:

NCT07664553

Conditions

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elecoglipron

Placebo

Study Details

Brief summary:

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)

Conditions

Type 2 Diabetes Mellitus

Study ID

NCT07664553

Start date

Jul 8, 2026

Status verified date

Jul, 2026

Completion date

May 23, 2028

Anticipated

Primary completion date

May 23, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elecoglipron dose level 1

Participants will receive elecoglipron at dose level 1 administered orally once daily.

experimental: Elecoglipron dose level 2

Participants will receive elecoglipron at dose level 2 administered orally once daily.

placebo comparator: Placebo

Participants will receive placebo administered orally once daily.

Interventions

Elecoglipron

Elecoglipron is administered orally once daily.

Placebo

Placebo is administered orally once daily.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Ocoee, Florida, United States, 34761

Research Site

Recruiting

Vancouver, British Columbia, Canada, V5Y 3W2

Research Site

Recruiting

Toronto, Ontario, Canada, M4G3E8

More Information

Sponsor

AstraZeneca

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.