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NCT Number: NCT07662213

A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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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 Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
  • T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)
  • HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
  • Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors
  • 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

  • Type 1 Diabetes Mellitus (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 Gastrointestinal (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.

semaglutide

Drug

Semaglutide is administered orally once daily.

Primary outcomes

  1. Change from baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline to Week 52

Secondary outcomes

  1. Percent change from baseline to Week 52 in body weight

    Time frame: Baseline to Week 52

  2. Change from baseline to Week 52 in body weight (kg)

    Time frame: Baseline to Week 52

  3. Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52

    Time frame: Baseline to Week 52

  4. Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52

    Time frame: Week 52

  5. Achieved HbA1c < 7% (53 mmol/mol) at Week 52

    Time frame: Week 52

  6. Achieved ≥ 5% weight loss from baseline at Week 52

    Time frame: Baseline to Week 52

  7. Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP

    Time frame: Baseline to Week 52

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, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Oral Semaglutide in Adults With Type 2 Diabetes Mellitus (Eluminate-2)

Acronym: Eluminate-2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 23, 2026
Registry last updated
Jul 14, 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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