A Phase 3 interventional study of Empagliflozin (oral) and Matching placebo in Metabolic Syndrome, sponsored by The University of Hong Kong. Enrolling by invitation at 1 site in Hong Kong. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by The University of Hong Kong · Phase 3, Interventional, and Treatment
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 160 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Empagliflozin (oral)
Other: Matching placebo
Participants received Empagliflozin 10 mg orally once daily for six months.
Participants received matching placebo orally once daily for six months.
The change in the continuous metabolic syndrome risk score
Time frame: From enrolment to the final visit at 6 months
Serum level of adiponectin, AFABP, FGF21, lipocalin-2
Time frame: From enrolment to the final visit at 6 months
Body weight
Time frame: From enrolment to the final visit at 6 months
Waist circumference
Time frame: From enrolment to the final visit at 6 months
Sagittal abdominal diameter
Time frame: From enrolment to the final visit at 6 months
Serum triglycerides
Time frame: From enrolment to the final visit at 6 months
Serum HDL
Time frame: From enrolment to the final visit at 6 months
Fasting glucose
Time frame: From enrolment to the final visit at 6 months
HbA1c
Time frame: From enrolment to the final visit at 6 months
HOMA2-IR
Time frame: From enrolment to the final visit at 6 months
HOMA2-B
Time frame: From enrolment to the final visit at 6 months
Systolic and diastolic blood pressure
Time frame: From enrolment to the final visit at 6 months
The number of abnormal components of the metabolic syndrome in the subject
Time frame: From enrolment to the final visit at 6 months
Plan to share: Yes — The de-identified individual participant data that underlie the results reported in this publication.
Supporting information: Study protocol
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The University of Hong Kong