A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin

NCT07662135
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
900
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Lead sponsor
AstraZeneca
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Start date
2026-07-06
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Number of sites
186
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Summary
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) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).
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Acronym
Eluminate-4
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Short title
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin
clinicaltrials.gov
Official 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 and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)
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Control arm
Placebo
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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
2028-07-13
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First posted
2026-06-23
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Registry last updated
2026-09-02
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Primary completion date
2028-07-13
clinicaltrials.gov
Start date
2026-07-06
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Participants
900
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Participant count basis
Estimated
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Planned participants
900
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Protocol amendments
0
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Number of sites
186
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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
NCT07662135
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07662135
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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. Achievement of HbA1c < 7% (53 mmol/mol)

    Timeframe: Week 40

  2. Achievement of HbA1c ≤ 6.5% (48 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 Systolic Blood Pressure (SBP)

    Timeframe: Baseline to Week 40

  6. Achievement of HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia)

    Timeframe: Baseline to Week 40

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

    Timeframe: Baseline to Week 40

  8. Time to initiation of rescue medication over 40 weeks

    Timeframe: Baseline to Week 40

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

    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 for at least 90 days prior to screening

  • On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)

  • HbA1c value:

    1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
    2. SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)

  • Impaired renal function

  • 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 SiteSun City, United StatesNot yet recruiting
  • Research SiteSurprise, United StatesNot yet recruiting
  • Research SiteConcord, United StatesNot yet recruiting
  • Research SiteSacramento, United StatesRecruiting
  • Research SiteVictorville, United StatesNot yet recruiting
  • Research SiteFleming Island, United StatesNot yet recruiting
  • Research SiteLauderdale Lakes, United StatesNot yet recruiting
  • Research SiteLeesburg, United StatesNot yet recruiting
  • Research SiteMiami Lakes, United StatesRecruiting
  • Research SiteOcoee, United StatesRecruiting
  • Research SiteOrlando, United StatesNot yet recruiting
  • Research SiteChicago, United StatesNot yet recruiting
  • Research SiteBraintree, United StatesNot yet recruiting
  • Research SiteNew Bedford, United StatesNot yet recruiting
  • Research SiteWorcester, United StatesNot yet recruiting
  • Research SiteSaint Joseph, United StatesSuspended
  • Research SiteSaint Paul, United StatesNot yet recruiting
  • Research SiteKansas City, United StatesRecruiting
  • Research SiteOmaha, United StatesNot yet recruiting
  • Research SiteLas Vegas, United StatesNot yet recruiting
  • Research SiteAlbuquerque, United StatesRecruiting
  • Research SiteThe Bronx, United StatesNot yet recruiting
  • Research SiteKinston, United StatesNot yet recruiting
  • Research SiteRaleigh, United StatesRecruiting
  • Research SiteWinston-Salem, United StatesNot yet recruiting

And 161 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523940-12-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)