Clinical trial NCT06352177: Digital Therapeutic Lifestyle Intervention Program for Patients with MASLD
Official title: Efficacy of a Novel Digital Therapeutic Lifestyle Intervention Program for Patients with MASLD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NASH
NASH - Nonalcoholic Steatohepatitis
Liver Diseases
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomization
Primary purpose: TREATMENT

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.).


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years at the time of signing informed consent
2. MASH defined by any of the following within 12-months prior to SV (V1):

   1. Liver biopsy with definitive MASH with NAS \>4 with \>1 in each component (i.e., steatosis, lobular inflammation, ballooning) or;
   2. 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
3. Possession of a smartphone (iPhone6s or newer with iOS version 15.6 or above; Android device with Android version 6 or above)
4. 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.
5. Stable body weight for 3 mos. before screening visit defined as \<5% weight loss or weight gain

Exclusion Criteria:

1. Recent (within 3 mos. of SV) participation in lifestyle intervention program or use of supplements marked for weight loss or appetite.
2. Plans to undergo bariatric surgery or initiate anti-obesity medication.
3. History of cirrhosis and/or hepatic decompensation (e.g., ascites, encephalopathy, variceal bleeding)
4. Liver disease of other etiologies (e.g., viral hepatitis), including liver transplantation
5. History of excessive alcohol consumption defined by self-report (men \>30g/d or women \>20g/d), AUDIT-C \>4 or PETH \> 20ug/L
6. History of malignancy within last 5 yrs., excluding successful treatment of non-melanoma skin cancer
7. Participant in any clinical trial or use of drugs under investigation for treatment of MASH within 3 mos. of SV
8. History of type 1 diabetes or uncontrolled type 2 diabetes (A1c \>9.5% or changes in diabetes medication doses within 3 mos. of SV)
9. Recent (within 3 mos. of SV) initiation or change in dose of medications used to treat MASH (e.g., vitamin E, pioglitazone)
10. Recent (within 3 mos. of SV) use of drugs associated with the development of steatotic liver disease (e.g., methotrexate, tamoxifen)
11. Known or suspected history of drug abuse within the last 2 years prior to SV at the discretion of study investigator
12. Vulnerable participants (e.g., protected adults under guardianship or committed to an institution by governmental or judicial order)
13. Participants who cannot communicate with the study investigators or use digital technology reliably
14. Severe medical comorbidities that may hinder study participation at the discretion of study investigator
15. Current pregnancy or plans to become pregnant during the study period

Primary outcomes:
measure: Clinically significant liver fat loss
timeFrame: 16 weeks
Secondary outcomes:
measure: Sustained clinically significant body weight loss
timeFrame: 16 weeks
measure: Sustained clinically significant body weight loss
timeFrame: 52 weeks
measure: Liver fat and liver stiffness using imaging analysis
timeFrame: 16 weeks
measure: Liver fat and liver stiffness using imaging analysis
timeFrame: 16 weeks
measure: Liver fat and liver stiffness using imaging analysis
timeFrame: 16 weeks
measure: Liver fat and liver stiffness using imaging analysis
timeFrame: 52 weeks
measure: Liver fat and liver stiffness using imaging analysis
timeFrame: 52 weeks
measure: Liver fat and liver stiffness using imaging analysis
timeFrame: 52 weeks
measure: Clinically meaningful improvement in liver fat and stiffness
timeFrame: 16 weeks
measure: Clinically meaningful improvement in liver fat and stiffness
timeFrame: 16 weeks
measure: Clinically meaningful improvement in liver fat and stiffness
timeFrame: 16 weeks
measure: Clinically meaningful improvement in liver fat and stiffness
timeFrame: 52 weeks
measure: Clinically meaningful improvement in liver fat and stiffness
timeFrame: 52 weeks
measure: Clinically meaningful improvement in liver fat and stiffness
timeFrame: 52 weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 16 Weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 16 Weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 16 Weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 16 Weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 16 Weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 16 Weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 16 Weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 52 weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 52 weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 52 weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 52 weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 52 weeks
measure: Circulating biomarkers of hepatic injury
timeFrame: 52 weeks
measure: Circulating biomarkers of liver fibrosis and fibrogenesis
timeFrame: 16 Weeks
measure: Circulating biomarkers of liver fibrosis and fibrogenesis
timeFrame: 16 Weeks
measure: Circulating biomarkers of liver fibrosis and fibrogenesis
timeFrame: 16 Weeks
measure: Circulating biomarkers of liver fibrosis and fibrogenesis
timeFrame: 52 weeks
measure: Circulating biomarkers of liver fibrosis and fibrogenesis
timeFrame: 52 weeks
measure: Circulating biomarkers of liver fibrosis and fibrogenesis
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
References: