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

NCT07662213
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,200
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Lead sponsor
AstraZeneca
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Start date
2026-07-06
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Number of sites
201
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Summary
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).
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Acronym
Eluminate-2
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Short title
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
clinicaltrials.gov
Official 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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-05-23
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First posted
2026-06-23
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Registry last updated
2026-07-14
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Primary completion date
2028-05-23
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Start date
2026-07-06
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Participants
1,200
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Participant count basis
Estimated
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Planned participants
1,200
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Protocol amendments
0
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Number of sites
201
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07662213
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ClinicalTrials.gov ID
NCT07662213
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Change from baseline in Hemoglobin A1c (HbA1c)

    Timeframe: Baseline to Week 52

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

    Timeframe: Baseline to Week 52

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

    Timeframe: Baseline to Week 52

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

    Timeframe: Baseline to Week 52

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

    Timeframe: Week 52

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

    Timeframe: Week 52

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

    Timeframe: Baseline to Week 52

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

    Timeframe: Baseline to Week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Research SiteBirmingham, United StatesNot yet recruiting
  • Research SiteMesa, United StatesNot yet recruiting
  • Research SitePhoenix, United StatesNot yet recruiting
  • Research SiteTempe, United StatesNot yet recruiting
  • Research SiteCovina, United StatesNot yet recruiting
  • Research SiteEncinitas, United StatesNot yet recruiting
  • Research SiteGarden Grove, United StatesNot yet recruiting
  • Research SiteLoma Linda, United StatesNot yet recruiting
  • Research SiteLong Beach, United StatesNot yet recruiting
  • Research SitePomona, United StatesNot yet recruiting
  • Research SiteSacramento, United StatesNot yet recruiting
  • Research SiteBridgeport, United StatesNot yet recruiting
  • Research SiteCrystal River, United StatesNot yet recruiting
  • Research SiteHollywood, United StatesNot yet recruiting
  • Research SiteJacksonville, United StatesNot yet recruiting
  • Research SiteLeesburg, United StatesNot yet recruiting
  • Research SiteOrlando, United StatesNot yet recruiting
  • Research SiteLilburn, United StatesNot yet recruiting
  • Research SiteIdaho Falls, United StatesNot yet recruiting
  • Research SiteMelrose Park, United StatesNot yet recruiting
  • Research SiteEvansville, United StatesNot yet recruiting
  • Research SiteAmes, United StatesNot yet recruiting
  • Research SiteWichita, United StatesNot yet recruiting
  • Research SiteBowling Green, United StatesNot yet recruiting
  • Research SiteRockville, United StatesNot yet recruiting

And 176 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523933-24-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)