NCT07065357

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

Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor: a Randomised Controlled Trial

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Empagliflozin (oral)	Participants received Empagliflozin 10 mg orally once daily for six months.
OTHER	Matching placebo	Participants received matching placebo orally once daily for six months.

Timeline

• Start date: 2025-08-13
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-07-15
• Last updated: 2025-08-24

Locations

1 site across 1 country: Hong Kong