Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD

Liver Diseases Clinical Trial

— ENLIGHTEN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352177
• Other study ID #: protocol-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2025
• Est. completion date: August 1, 2030

Study information

• Verified date: April 2024
• Source: Milton S. Hershey Medical Center
• Contact: Breianna Hummer-Bair, MS
• Phone: 717-531-0003
• Email: bhummer[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

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.).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. BMI >25 kg/mx

4. Possession of a smartphone (iPhone6s or newer with iOS version 15.6 or above; Android device with Android version 6 or above)

5. 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.

6. 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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NASH
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• Noom Weight Application
This commercially available program (Noom Weight) promotes clinically significant body weight loss and behavior change in multiple populations. The program is delivered through a smartphone application and includes self-monitoring and feedback features for diet, physical activity, and body weight, as well as digital access to a 1:1 behavior change coach, a support group facilitated by a health coach, and a curriculum delivered via daily articles focused on nutrition, physical activity, and sustainable behavioral change.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant liver fat loss	Proportion of participants achieving >30% relative reduction in MRI-PDFF after Wk. 16.	16 weeks
Secondary	Sustained clinically significant body weight loss	Proportion of participants achieving >5% body weight loss after Wk. 16.	16 weeks
Secondary	Sustained clinically significant body weight loss	Proportion of participants achieving >5% body weight loss after Wk. 48.	48 weeks
Secondary	Liver fat and liver stiffness using imaging analysis	• VCTE will assess change in liver fat and stiffness at Wks. 16	16 weeks
Secondary	Liver fat and liver stiffness using imaging analysis	• MRI-PDFF will assess change in liver fat at Wks. 16	16 weeks
Secondary	Liver fat and liver stiffness using imaging analysis	• MRE will assess change in liver stiffness at Wks. 16	16 weeks
Secondary	Liver fat and liver stiffness using imaging analysis	• VCTE will assess change in liver fat and stiffness at Wks. 48.	48 weeks
Secondary	Liver fat and liver stiffness using imaging analysis	• MRI-PDFF will assess change in liver fat at Wks. 48.	48 weeks
Secondary	Liver fat and liver stiffness using imaging analysis	• MRE will assess change in liver stiffness at Wks. 48	48 weeks
Secondary	Clinically meaningful improvement in liver fat and stiffness	• Proportion of participants with >26% relative reduction in VCTE-measured liver stiffness (kPA) after Wks. 16	16 weeks
Secondary	Clinically meaningful improvement in liver fat and stiffness	• Proportion of participants with >30% relative reduction in MRI-PDFF after Wk. 16	16 weeks
Secondary	Clinically meaningful improvement in liver fat and stiffness	• Proportion of participants with >15% decrease in MRE-measured liver stiffness (kPA) after Wks. 16	16 weeks
Secondary	Clinically meaningful improvement in liver fat and stiffness	• Proportion of participants with >26% relative reduction in VCTE-measured liver stiffness (kPA) after Wks. 48.	48 weeks
Secondary	Clinically meaningful improvement in liver fat and stiffness	• Proportion of participants with >30% relative reduction in MRI-PDFF after Wk. 48.	48 weeks
Secondary	Clinically meaningful improvement in liver fat and stiffness	• Proportion of participants with >15% decrease in MRE-measured liver stiffness (kPA) after Wks.48	48 weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in ALT after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of hepatic injury	• Proportion of participants with >17 IU/L decrease in ALT96 after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in AST after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in CK-18 after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in GGT after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in NASH Fibrotic Index after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of hepatic injury	• Proportion of participants with >17 IU/L decrease in ALT96 after Wks. 16.	16 Weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in ALT after Wks. 48.	48 weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in AST after Wks. 48.	48 weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in CK-18 after Wks. 48.	48 weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in GGT after Wks. 48.	48 weeks
Secondary	Circulating biomarkers of hepatic injury	• Change in NASH Fibrotic Index after Wks. 48.	48 weeks
Secondary	Circulating biomarkers of hepatic injury	• Proportion of participants with >17 IU/L decrease in ALT96 after Wks. 48.	48 weeks
Secondary	Circulating biomarkers of liver fibrosis and fibrogenesis	• Change in Enhanced Liver Fibrosis (ELF) score after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of liver fibrosis and fibrogenesis	• Change in Fibrosis-4 index (FIB-4) after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of liver fibrosis and fibrogenesis	• Change in PRO-C3 after Wks. 16	16 Weeks
Secondary	Circulating biomarkers of liver fibrosis and fibrogenesis	• Change in Enhanced Liver Fibrosis (ELF) score after Wks. 48.	48 weeks
Secondary	Circulating biomarkers of liver fibrosis and fibrogenesis	• Change in Fibrosis-4 index (FIB-4) after Wks. 48.	48 weeks
Secondary	Circulating biomarkers of liver fibrosis and fibrogenesis	• Change in PRO-C3 after Wks. 48.	48 weeks