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RecruitingPhase 3

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

AstraZeneca · NCT07664553

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
600
US sites recruiting
1
Study start
July 8, 2026
Record last updated
August 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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)

Being studied: Elecoglipron; Placebo

Conditions: Type 2 Diabetes Mellitus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
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A Phase III Study to Investigate the Efficacy and Safety of… (NCT07664553) | Bored Studies