Cushing Syndrome
Conditions
Brief summary
The primary efficacy endpoint is the change in area under the curve for glucose (AUCglucose) based on the 2-hour oGTT at week 12 versus baseline during each of the 12-week treatment periods.
Detailed description
The change in AUCglucose based on the 2-hour oGTT at week 6 versus baseline during each of the 12-week treatment periods., The change in HbA1c at weeks 6 and 12 versus baseline during each of the 12-week treatment periods, The change in serum lipid profiles at weeks 6 and 12 versus baseline during each of the 12-week treatment periods, The change in body habitus as evaluated by DEXA scanning at weeks 6 and 12 versus baseline during each of the 12-week treatment periods, The change in hepatic steatosis/fibrosis as evaluated by TEand MRI-PDFF at week 12 versus baseline during each of the 12-week treatment periods.
Interventions
DRUGFluasterone Buccal Tablet
Sponsors
Sterotherapeutics LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The change in AUCglucose based on the 2-hour oGTT at week 6 versus baseline during each of the 12-week treatment periods., The change in HbA1c at weeks 6 and 12 versus baseline during each of the 12-week treatment periods, The change in serum lipid profiles at weeks 6 and 12 versus baseline during each of the 12-week treatment periods, The change in body habitus as evaluated by DEXA scanning at weeks 6 and 12 versus baseline during each of the 12-week treatment periods, The change in hepatic steatosis/fibrosis as evaluated by TEand MRI-PDFF at week 12 versus baseline during each of the 12-week treatment periods. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the change in area under the curve for glucose (AUCglucose) based on the 2-hour oGTT at week 12 versus baseline during each of the 12-week treatment periods. | — |
Countries
Greece
Outcome results
None listed