Empagliflozin Phase 3 Trial for Metabolic Syndrome Reaches Primary Completion

The DEMETER - SIRIO 11 study (NCT05905965), a Phase 3 trial investigating the efficacy of a double dose versus a standard dose of empagliflozin for metabolic syndrome treatment, reached its primary completion on 2025-12-31. This multicenter, randomized, open-label, investigator-initiated clinical trial aims to evaluate the impact of different empagliflozin doses on key metabolic parameters over a 6-month follow-up period.

Background

Empagliflozin is being investigated in the DEMETER - SIRIO 11 study for its potential role in treating Metabolic Syndrome. Metabolic syndrome is a cluster of conditions that occur together, increasing your risk of heart disease, stroke, and type 2 diabetes. The trial specifically compares two doses of empagliflozin to assess their relative efficacy.

Trial design

The DEMETER - SIRIO 11 study (NCT05905965) is a Phase 3, multicenter, randomized, open-label, investigator-initiated clinical trial. It has an enrollment target of 200 subjects, all diagnosed with Metabolic Syndrome. Participants are randomly assigned in a 1:1 ratio to one of two study arms: an experimental arm receiving empagliflozin 20 mg or a control arm receiving empagliflozin 10 mg. The study has a 6-month follow-up period. Primary co-endpoints for the study include BMI and HbA1c. Secondary endpoints include LDL-C, triglycerides, CRP, NT-proBNP, LVEF (echocardiography), body composition, and VO2max (ergospiro).

What this means

The primary completion of the DEMETER - SIRIO 11 study marks a significant milestone in the evaluation of empagliflozin for Metabolic Syndrome. While specific efficacy results are not yet available, the completion of this Phase 3 trial indicates that all planned participant follow-up for the primary endpoints has concluded. The study's focus on comparing a double dose (20 mg) against a standard dose (10 mg) of empagliflozin for effects on critical metabolic markers like BMI and HbA1c could provide valuable insights into optimal dosing strategies for managing metabolic syndrome. Clinicians and researchers will anticipate the release of the trial's detailed results to understand the comparative efficacy and safety profile of these different doses in this patient population.

Source

Information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The event for study NCT05905965, titled "Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment," was recorded as primary completion on 2025-12-31 on clinicaltrials.gov.