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NCT Number: NCT07664553

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

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)

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, East Toowoomba, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elecoglipron

Drug

Elecoglipron is administered orally once daily.

Placebo

Drug

Placebo is administered orally once daily.

Primary outcomes

  1. Change from baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline to Week 40

    Summary statistics

Secondary outcomes

  1. Achieved HbA1c < 7% (53 mmol/mol) at Week 40

    Time frame: Week 40

  2. Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40

    Time frame: Week 40

  3. Percent change from baseline to Week 40 in body weight

    Time frame: Baseline to Week 40

  4. Change from baseline to Week 40 in body weight (kg)

    Time frame: Baseline to Week 40

  5. Change from baseline to Week 40 in Systolic blood pressure (SBP)

    Time frame: Baseline to Week 40

  6. Change from baseline to Week 40 in fasting plasma glucose (FPG)

    Time frame: Baseline to Week 40

  7. Achieved HbA1c < 7% (53 mmol/mol) at Week 40 without hypoglycemia (glucose < 54 mg/dL [3.0 mmol/L] or severe hypoglycemia)

    Time frame: Baseline to Week 40

  8. Change from baseline to Week 40 in daily mean 7-point self-monitoring blood glucose (SMBG)

    Time frame: Baseline to Week 40

  9. Change from baseline to Week 40 in diastolic blood pressure (DBP)

    Time frame: Baseline to Week 40

  10. Change from baseline to Week 40 in total daily insulin dose (IU)

    Time frame: Baseline to Week 40

  11. Discontinued insulin by Week 40

    Time frame: Baseline to Week 40

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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)

Acronym: Eluminate-3

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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