NASHENLIGHTENNCT06352177
Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD
A study testing Noom Weight Application in people with NASH and NASH - Nonalcoholic Steatohepatitis, run by Milton S. Hershey Medical Center.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH, NASH - Nonalcoholic Steatohepatitis, Liver Diseases
- What is being tested?
- Noom Weight Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
- Known or suspected history of drug abuse within the last 2 years prior to SV at the discretion of study investigator
- Vulnerable participants (e.g., protected adults under guardianship or committed to an institution by governmental or judicial order)
- Participants who cannot communicate with the study investigators or use digital technology reliably
- Severe medical comorbidities that may hinder study participation at the discretion of study investigator
- Current pregnancy or plans to become pregnant during the study period
About this study
Official title: Efficacy of a Novel Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD
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.).
- Conditions
- NASH, NASH - Nonalcoholic Steatohepatitis, Liver Diseases
- Being tested
- Noom Weight Application
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noom Weight ApplicationOther
Also called NW
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants in this group will receive counseling about best MASLD clinical practices in accordance with AASLD and ACSM practice guidelines Because in-office hepatology counseling for lifestyle intervention occurs every 12-24 wks,standard counseling will occur at each in-person visit. Mediterranean-informed, hypocaloric dietary counseling will be provided by a study investigator, with specific instructions to limit carbohydrates and saturated fat and enrich dietary intake with high fiber and unsaturated fats. Physical activity goals of 150 min/wk. of moderate intensity of 75 min/wk. of vigorous intensity activity will be suggested. To reinforce this education and promote self-monitoring, participants in this group will also receive a digital scale and fitness activity tracker. |
| Intervention | Experimental | This commercially available program (Noom Weight) promotes clinically significant body weight loss and behavior change in multiple populations including our pilot study in individuals with MASLD. 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. Receives: Other: Noom Weight Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant liver fat loss
Proportion of participants achieving >30% relative reduction in MRI-PDFF after Wk. 16.
Measured: 16 weeks
Secondary outcomes (33)
Sustained clinically significant body weight loss
Proportion of participants achieving >5% body weight loss after Wk. 16.
Measured: 16 weeks
Sustained clinically significant body weight loss
Proportion of participants achieving >5% body weight loss after Wk. 52
Measured: 52 weeks
Liver fat and liver stiffness using imaging analysis
- VCTE will assess change in liver fat and stiffness at Wks. 16
Measured: 16 weeks
Liver fat and liver stiffness using imaging analysis
- MRI-PDFF will assess change in liver fat at Wks. 16
Measured: 16 weeks
Liver fat and liver stiffness using imaging analysis
- MRE will assess change in liver stiffness at Wks. 16
Measured: 16 weeks
Liver fat and liver stiffness using imaging analysis
VCTE will assess change in liver fat and stiffness at Wks. 52.
Measured: 52 weeks
Liver fat and liver stiffness using imaging analysis
- MRI-PDFF will assess change in liver fat at Wks. 52.
Measured: 52 weeks
Liver fat and liver stiffness using imaging analysis
- MRE will assess change in liver stiffness at Wks. 52
Measured: 52 weeks
Clinically meaningful improvement in liver fat and stiffness
- Proportion of participants with >26% relative reduction in VCTE-measured liver stiffness (kPA) after Wks. 16
Measured: 16 weeks
Clinically meaningful improvement in liver fat and stiffness
- Proportion of participants with >30% relative reduction in MRI-PDFF after Wk. 16
Measured: 16 weeks
Clinically meaningful improvement in liver fat and stiffness
- Proportion of participants with >15% decrease in MRE-measured liver stiffness (kPA) after Wks. 16
Measured: 16 weeks
Clinically meaningful improvement in liver fat and stiffness
- Proportion of participants with >26% relative reduction in VCTE-measured liver stiffness (kPA) after Wks. 52
Measured: 52 weeks
Clinically meaningful improvement in liver fat and stiffness
- Proportion of participants with >30% relative reduction in MRI-PDFF after Wk. 52
Measured: 52 weeks
Clinically meaningful improvement in liver fat and stiffness
- Proportion of participants with >15% decrease in MRE-measured liver stiffness (kPA) after Wks. 52
Measured: 52 weeks
Circulating biomarkers of hepatic injury
- Change in ALT after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of hepatic injury
- Proportion of participants with >17 IU/L decrease in ALT after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of hepatic injury
- Change in AST after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of hepatic injury
- Change in CK-18 after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of hepatic injury
- Change in GGT after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of hepatic injury
- Change in NASH Fibrotic Index after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of hepatic injury
- Proportion of participants with >17 IU/L decrease in ALT after Wks. 16.
Measured: 16 Weeks
Circulating biomarkers of hepatic injury
- Change in ALT after Wks. 52
Measured: 52 weeks
Circulating biomarkers of hepatic injury
- Change in AST after Wks. 52
Measured: 52 weeks
Circulating biomarkers of hepatic injury
- Change in CK-18 after Wks. 52
Measured: 52 weeks
Circulating biomarkers of hepatic injury
- Change in GGT after Wks. 48.
Measured: 52 weeks
Circulating biomarkers of hepatic injury
- Change in NASH Fibrotic Index after Wks. 52.
Measured: 52 weeks
Circulating biomarkers of hepatic injury
- Proportion of participants with >17 IU/L decrease in ALT after Wks. 52
Measured: 52 weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
- Change in Enhanced Liver Fibrosis (ELF) score after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
- Change in Fibrosis-4 index (FIB-4) after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
- Change in PRO-C3 after Wks. 16
Measured: 16 Weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
- Change in Enhanced Liver Fibrosis (ELF) score after Wks. 52
Measured: 52 weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
- Change in Fibrosis-4 index (FIB-4) after Wks. 52
Measured: 52 weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
- Change in PRO-C3 after Wks. 52
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Why it stopped: Principal investigator left the institution and study was never funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Patton, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352177
- Sponsor's protocol ID
- protocol-1
- Acronym
- ENLIGHTEN
- Status last verified
- Jul 2025
- First submitted
- 8 Feb 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For this project, we anticipate data from 120 participants enrolled into the ENLIGHTEN study. There will be ten data collection points over the study duration. We will collect demographic, clinical, quality of life and outcomes information. Data will be converted to SAS and csv formats for analysis and sharing. To protect research participant personal identifying information (PII) and protected health information (PHI), all data will be de-identified prior to receipt by the repository and sharing in accordance with guidance provided for Limited Data Sets and Data Use Agreements section of NIH HIPAA Privacy Rule summary.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD
- ClinicalTrials.gov ID
- NCT06352177
- Acronym / sponsor ID
- ENLIGHTEN / protocol-1
- Conditions
- NASH, NASH - Nonalcoholic Steatohepatitis, Liver Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator left the institution and study was never funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants in this group will receive counseling about best MASLD clinical practices in accordance with AASLD and ACSM practice guidelines Because in-office hepatology counseling for lifestyle intervention occurs every 12-24 wks,standard counseling will occur at each in-person visit. Mediterranean-informed, hypocaloric dietary counseling will be provided by a study investigator, with specific instructions to limit carbohydrates and saturated fat and enrich dietary intake with high fiber and unsaturated fats. Physical activity goals of 150 min/wk. of moderate intensity of 75 min/wk. of vigorous intensity activity will be suggested. To reinforce this education and promote self-monitoring, participants in this group will also receive a digital scale and fitness activity tracker. |
| Intervention | Experimental | Other: Noom Weight ApplicationThis commercially available program (Noom Weight) promotes clinically significant body weight loss and behavior change in multiple populations including our pilot study in individuals with MASLD. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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):
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noom Weight ApplicationAlso: NWThis 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. | Other | Intervention |
Primary outcome
Clinically significant liver fat loss
Time frame: 16 weeks
Proportion of participants achieving >30% relative reduction in MRI-PDFF after Wk. 16.
33 secondary outcomes
Sustained clinically significant body weight loss
Time frame: 16 weeks
Sustained clinically significant body weight loss
Time frame: 52 weeks
Liver fat and liver stiffness using imaging analysis
Time frame: 16 weeks
Liver fat and liver stiffness using imaging analysis
Time frame: 16 weeks
Liver fat and liver stiffness using imaging analysis
Time frame: 16 weeks
Liver fat and liver stiffness using imaging analysis
Time frame: 52 weeks
Liver fat and liver stiffness using imaging analysis
Time frame: 52 weeks
Liver fat and liver stiffness using imaging analysis
Time frame: 52 weeks
Clinically meaningful improvement in liver fat and stiffness
Time frame: 16 weeks
Clinically meaningful improvement in liver fat and stiffness
Time frame: 16 weeks
Clinically meaningful improvement in liver fat and stiffness
Time frame: 16 weeks
Clinically meaningful improvement in liver fat and stiffness
Time frame: 52 weeks
Clinically meaningful improvement in liver fat and stiffness
Time frame: 52 weeks
Clinically meaningful improvement in liver fat and stiffness
Time frame: 52 weeks
Circulating biomarkers of hepatic injury
Time frame: 16 Weeks
Circulating biomarkers of hepatic injury
Time frame: 16 Weeks
Circulating biomarkers of hepatic injury
Time frame: 16 Weeks
Circulating biomarkers of hepatic injury
Time frame: 16 Weeks
Circulating biomarkers of hepatic injury
Time frame: 16 Weeks
Circulating biomarkers of hepatic injury
Time frame: 16 Weeks
Circulating biomarkers of hepatic injury
Time frame: 16 Weeks
Circulating biomarkers of hepatic injury
Time frame: 52 weeks
Circulating biomarkers of hepatic injury
Time frame: 52 weeks
Circulating biomarkers of hepatic injury
Time frame: 52 weeks
Circulating biomarkers of hepatic injury
Time frame: 52 weeks
Circulating biomarkers of hepatic injury
Time frame: 52 weeks
Circulating biomarkers of hepatic injury
Time frame: 52 weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
Time frame: 16 Weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
Time frame: 16 Weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
Time frame: 16 Weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
Time frame: 52 weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
Time frame: 52 weeks
Circulating biomarkers of liver fibrosis and fibrogenesis
Time frame: 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. For this project, we anticipate data from 120 participants enrolled into the ENLIGHTEN study. There will be ten data collection points over the study duration. We will collect demographic, clinical, quality of life and outcomes information. Data will be converted to SAS and csv formats for analysis and sharing. To protect research participant personal identifying information (PII) and protected health information (PHI), all data will be de-identified prior to receipt by the repository and sharing in accordance with guidance provided for Limited Data Sets and Data Use Agreements section of NIH HIPAA Privacy Rule summary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Noom Weight Application in people with NASH and NASH - Nonalcoholic Steatohepatitis, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant liver fat loss (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.