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Clinical Trials in the EU / 2025-523940-12-00
Authorised, recruiting Phase III

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)

2025-523940-12-00 · tracked via the Priya Life Science EU tracker
Sponsor
AstraZeneca AB
Sponsor type
Pharmaceutical company
Therapeutic area
Nutritional and Metabolic Diseases
Decision date
03/08/2026
Enrollment target
183
Sites
Germany, Bulgaria, Spain, Denmark

Condition studied

type 2 diabetes mellitus

Investigational medicinal product(s)

ElecoglipronPlacebo for Elecoglipron (AZD5004)Forxiga 10 mg film-coated tablets

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Change from baseline to Week 40 in HbA1c (%)

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523940-12-00 on CTIS ↗ ← All trials in the EU