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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.).
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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):
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
Primary purpose
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120 participants in 2 patient groups
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Central trial contact
Breianna Hummer-Bair, MS
Data sourced from clinicaltrials.gov
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