Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07065357 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor

Study acronym: TIME-SGLT2
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 24, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2025 to Aug 13, 2025
    v3
  2. Minor Secondary endpoints: 10 to 12
    • Study title shortened, about 4 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The metabolic syndrome occurs in overweight or obese people who also have abnormal lipids, blood pressure and blood glucose. It precedes the development of diabetes and cardiovascular complications. Currently, there are no drugs licensed for the treatment of the metabolic syndrome. Empagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor, originally developed for diabetes but has since been proven to be beneficial in patients with heart and kidney failure. By increasing glucose excretion in the urine, it reduces body weight, body fat and blood pressure. The investigators therefore hypothesize that it may be the ideal drug to reverse the metabolic syndrome. Search of clinical trials registries shows that there are no industry sponsored trials targeting patients with the metabolic syndrome. The investigators propose to conduct a randomised controlled trial to study the effects of empagliflozin on 160 people with the metabolic syndrome, who will be randomised to receive either empagliflozin or placebo. The primary hypothesis is that empagliflozin will reduce the metabolic syndrome risk score, while secondary outcome measures include circulating levels of adipokines (adiponectin, fibroblast growth factor 21, adipocyte fatty acid-binding protein and lipocalin-2), body weight, waist circumference, blood pressure, glucose and lipids. This drug has already been approved for use in diabetes and cardiovascular risk prevention. This study, if positive, would provide evidence for its use in the metabolic syndrome and the treatment for this syndrome for the first time.
Trial Details
NCT Number NCT07065357
Lead Sponsor The University of Hong Kong
Conditions
(from sponsor)
Metabolic Syndrome
Related terms Metabolic Syndrome
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov