Adding empagliflozin to reduce olanzapine-related weight gain and metabolic problems
Evaluating the Safety and Efficacy of Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients.A Double-Blind, Randomized, Placebo-Controlled Trial
This tests whether adding the diabetes drug empagliflozin to treatment for adults with schizophrenia who are taking olanzapine can reduce weight gain and other metabolic problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT05669742 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional trial gives empagliflozin in addition to ongoing olanzapine treatment to determine effects on olanzapine-associated metabolic disturbances. Adults aged 18–60 with schizophrenia on olanzapine are enrolled at Tanta University and followed over time for metabolic outcomes. Outcomes include changes in body weight, blood glucose, lipid levels, and blood pressure, with safety monitoring for adverse events and renal function. The protocol excludes participants with active inflammatory diseases and other major comorbidities.
Who should consider this trial
Good fit: Adults aged 18–60 with schizophrenia who are currently being treated with olanzapine and who meet the study's medical eligibility criteria are the intended participants.
Not a fit: Patients who have active inflammatory diseases or other major medical conditions excluded by the protocol, or those not taking olanzapine, are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding empagliflozin could reduce weight gain and lower the risk of diabetes and cardiovascular complications in people taking olanzapine.
How similar studies have performed: Previous meta-analyses have shown that antidiabetic drugs like metformin can improve antipsychotic-associated metabolic problems, but using empagliflozin specifically for olanzapine-induced metabolic effects is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Schizophrenia Patients treated with Olanzapine with ages ranging from 18 to 60 years. Exclusion Criteria: patients who had any other inflammatory disease (cardiovascular, asthma, bone
Where this trial is running
Tanta
- Tanta Unuversity — Tanta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.