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

Milton S. Hershey Medical Center0 sites120 target enrollmentSeptember 1, 2025

ConditionsNASH NASH - Nonalcoholic Steatohepatitis Liver Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: NASH
Sponsor: Milton S. Hershey Medical Center
Enrollment: 120
Primary Endpoint: Clinically significant liver fat loss
Status: Withdrawn
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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, 52-wk treatment period and 12-wk follow-up period (total duration up to 64 wks.).

Registry

clinicaltrials.gov

Start Date

September 1, 2025

End Date

April 1, 2030

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Milton S. Hershey Medical Center

Responsible Party

Principal Investigator

Stephanie Patton

Compliance Specialist, Penn State Health

Milton S. Hershey Medical Center

Eligibility Criteria

Inclusion Criteria

•Age 18-75 years at the time of signing informed consent
•MASH defined by any of the following within 12-months prior to SV (V1):
•Liver biopsy with definitive MASH with NAS \>4 with \>1 in each component (i.e., steatosis, lobular inflammation, ballooning) or;
•Imaging study (e.g., ultrasound) with hepatic steatosis and one of the following:
•i) FIB-4 \>1.3 or; ii) ELF test \>7.7 or; iii) VCTE measured liver stiffness \>8kPa or FAST score \>0.35 or; iv) MRE measured liver stiffness \>2.55kPa or MAST score \>0.165
•Possession of a smartphone (iPhone6s or newer with iOS version 15.6 or above; Android device with Android version 6 or above)
•If participants are on GLP1-RA or other regulatory agency approved anti-obesity medication (e.g., orlistat, buproprion/naltrexone, phentermine-topiramate, phentermine, loreaserin), the medication dose must be stable (no change in dose) for the 3 mos. before SV.
•Stable body weight for 3 mos. before screening visit defined as \<5% weight loss or weight gain

Exclusion Criteria

•Recent (within 3 mos. of SV) participation in lifestyle intervention program or use of supplements marked for weight loss or appetite.
•Plans to undergo bariatric surgery or initiate anti-obesity medication.
•History of cirrhosis and/or hepatic decompensation (e.g., ascites, encephalopathy, variceal bleeding)
•Liver disease of other etiologies (e.g., viral hepatitis), including liver transplantation
•History of excessive alcohol consumption defined by self-report (men \>30g/d or women \>20g/d), AUDIT-C \>4 or PETH \> 20ug/L
•History of malignancy within last 5 yrs., excluding successful treatment of non-melanoma skin cancer
•Participant in any clinical trial or use of drugs under investigation for treatment of MASH within 3 mos. of SV
•History of type 1 diabetes or uncontrolled type 2 diabetes (A1c \>9.5% or changes in diabetes medication doses within 3 mos. of SV)
•Recent (within 3 mos. of SV) initiation or change in dose of medications used to treat MASH (e.g., vitamin E, pioglitazone)
•Recent (within 3 mos. of SV) use of drugs associated with the development of steatotic liver disease (e.g., methotrexate, tamoxifen)