Eluminate-4
Research type
Research Study
Full 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)
IRAS ID
1013687
Contact name
James Beddoes
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Background: People with Type 2 Diabetes Mellitus (T2DM) have high blood sugar levels as their bodies do not make enough insulin. Insulin is a hormone that helps the body use sugar for energy. High blood sugar can cause damage to the kidneys. This damage produces problems whereby the kidneys cannot remove enough waste and fluid from the blood, causing serious health issues. Some people with T2DM also have obesity/excess body weight, this can contribute to other health problems. In people with T2DM, weight loss may help lower blood sugar levels and reduce the risk of other health problems.
Purpose: The trial drug elecoglipron can lower blood sugar levels and reduce appetite, this may help to better manage T2DM and support weight loss. Elecoglipron works like the glucagon-like peptide 1 (GLP-1) hormone in the body. GLP-1 helps to lower blood sugar by increasing insulin production, slowing digestion, and decreasing appetite. Most available medications that work like the GLP-1 hormone are taken as injections just under the skin. Elecoglipron is taken as a tablet by mouth, which is more convenient. In this trial, the researchers want to know how safe elecoglipron is and how well it works when taken by adults who are taking dapagliflozin to help manage their kidney problems. Dapagliflozin is a type of drug called SGLT2i and is used as a treatment for kidney problems and managing blood sugar levels in some people with T2DM.
Design: Phase 3, randomised (people randomly assigned to treatment group) , placebo-controlled (some people take a placebo that does not contain any active ingredient) , double-blind (no participant nor study team know treatment assignment).
Duration: 42wks
Population: 900, at least 18 years old, have T2DM and kidney problems
Treatment: Elecoglipron 45mg, 65mg or Placebo plus Dapagliflozin 10mg
Procedures: blood & urine tests, physical exams, vitals checks, electrocardiograms, questionnaires, self-reporting of medications and medical issues.REC name
London - Surrey Borders Research Ethics Committee
REC reference
26/LO/0275
Date of REC Opinion
17 Jun 2026
REC opinion
Further Information Favourable Opinion