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Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD — ENLIGHTEN  

Liver Diseases Clinical Trial

Official title:
Efficacy of a Novel Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD

Clinical Trial Summary

The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH. People who have MASH, the progressive subtype of MASLD, have the highest risk for liver disease progression and poor outcomes, including cirrhosis and hepatocellular carcinoma, and greater overall mortality. Thus, these participants are expected to experience the greatest benefit from treatment. This is a randomized, controlled trial comparing DTx lifestyle intervention in participants with non-cirrhotic MASH to standard clinical care. The study includes a screening period (up to 2 wks.) followed by randomization, 48-wk treatment period and 12-wk follow-up period (total duration up to 62 wks.).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06352177
Study type Interventional
Source Milton S. Hershey Medical Center
Contact Breianna Hummer-Bair, MS
Phone 717-531-0003
Email bhummer@pennstatehealth.psu.edu
Status Not yet recruiting
Phase N/A
Start date April 1, 2025
Completion date August 1, 2030
View Details
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