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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523940-12-00
Enrollment
93
Registered
2026-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Brief summary

Change from baseline to Week 40 in HbA1c (%)

Detailed description

Achieved HbA1c < 7% (53 mmol/mol) at Week 40, Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40, Percent change from baseline to Week 40 in body weight, Change from baseline to Week 40 in body weight (kg), Change from baseline to Week 40 in SBP, Achieved HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia) at Week 40, Change from baseline to Week 40 in FPG, Time to initiation of rescue medication over 40 weeks, Change from baseline to Week 40 in DBP

Interventions

DRUGElecoglipron
DRUGForxiga 10 mg film-coated tablets
DRUGPlacebo for Elecoglipron (AZD5004)

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline to Week 40 in HbA1c (%)—

Secondary

MeasureTime frame
Achieved HbA1c < 7% (53 mmol/mol) at Week 40, Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40, Percent change from baseline to Week 40 in body weight, Change from baseline to Week 40 in body weight (kg), Change from baseline to Week 40 in SBP, Achieved HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia) at Week 40, Change from baseline to Week 40 in FPG, Time to initiation of rescue medication over 40 weeks, Change from baseline to Week 40 in DBP—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 6, 2026