A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus

NCT07662109
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
2,000
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Lead sponsor
AstraZeneca
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Start date
2026-07-06
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Number of sites
282
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Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
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Acronym
Eluminate-5
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Short title
A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus
clinicaltrials.gov
Official title
A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared With Elecoglipron Alone and Dapagliflozin Alone, in Adults With Type 2 Diabetes Mellitus (Eluminate-5)
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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
2028-07-05
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First posted
2026-06-23
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Registry last updated
2026-08-04
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Primary completion date
2028-07-05
clinicaltrials.gov
Start date
2026-07-06
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Participants
2,000
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Participant count basis
Estimated
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Planned participants
2,000
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Protocol amendments
0
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Number of sites
282
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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
NCT07662109
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ClinicalTrials.gov ID
NCT07662109
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change from baseline in Hemoglobin A1c (HbA1c)

    Timeframe: Baseline to Week 40

  1. Change from baseline in Hemoglobin A1c (HbA1c)

    Timeframe: Baseline to Week 40

  2. Achievement of HbA1c < 7% (53 mmol/mol)

    Timeframe: Week 40

  3. Percent change in body weight

    Timeframe: Baseline to Week 40

  4. Change from baseline in body weight

    Timeframe: Baseline to Week 40

  5. Change from baseline in Fasting Plasma Glucose (FPG)

    Timeframe: Baseline to Week 40

  6. Change from baseline in daily mean 7-point Self-Monitored Blood Glucose (SMBG)

    Timeframe: Baseline to Week 40

  7. Achievement of ≥ 5% weight loss from baseline

    Timeframe: Baseline to Week 40

  8. Change from baseline in Systolic Blood Pressure (SBP)

    Timeframe: Baseline to Week 40

  9. Change from baseline in Diastolic Blood Pressure (DBP)

    Timeframe: Baseline to Week 40

  10. Time to initiation of rescue medication over 40 weeks

    Timeframe: Baseline to Week 40

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
  • HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
  • 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, 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 (New York Heart Association IV)
  • History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Sources for eligibility
clinicaltrials.gov

  • Research SiteHuntsville, United StatesNot yet recruiting
  • Research SiteMobile, United StatesNot yet recruiting
  • Research SiteSheffield, United StatesNot yet recruiting
  • Research SiteLittle Rock, United StatesNot yet recruiting
  • Research SiteBakersfield, United StatesNot yet recruiting
  • Research SiteLos Angeles, United StatesNot yet recruiting
  • Research SiteOntario, United StatesNot yet recruiting
  • Research SiteLake City, United StatesNot yet recruiting
  • Research SiteLakeland, United StatesNot yet recruiting
  • Research SiteAtlanta, United StatesNot yet recruiting
  • Research SiteChicago, United StatesNot yet recruiting
  • Research SiteSkokie, United StatesNot yet recruiting
  • Research SiteEvansville, United StatesNot yet recruiting
  • Research SiteSioux City, United StatesNot yet recruiting
  • Research SiteZachary, United StatesNot yet recruiting
  • Research SiteAnnapolis, United StatesNot yet recruiting
  • Research SiteLutherville-Timonium, United StatesNot yet recruiting
  • Research SiteOxon Hill, United StatesNot yet recruiting
  • Research SiteBoston, United StatesNot yet recruiting
  • Research SiteBoston, United StatesNot yet recruiting
  • Research SiteTroy, United StatesNot yet recruiting
  • Research SiteRidgeland, United StatesNot yet recruiting
  • Research SiteElkhorn, United StatesNot yet recruiting
  • Research SiteAlbuquerque, United StatesNot yet recruiting
  • Research SiteBrooklyn, United StatesNot yet recruiting

And 257 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523941-81-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)