NASHCALIBRENCT06879236
Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease
An observational study of NASH and NAFLD, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The prevalence of Metabolic dysfunction-associated steatotic liver disease (MASLD) and its severe form, Metabolic dysfunction-associated steatohepatitis (MASH), is high and they are increasingly becoming major causes of cirrhosis, hepatocellular carcinoma (HCC), and the need for liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 252 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jan 2025to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with type 2 diabetes and/or metabolic syndrome and/or dyslipidemia and/or obesity (BMI>30 Kg/m2) and/or familiar history for cirrhosis or liver cancer in the absence of known risk factors
Who may be able to join
- Diagnosed with MASLD and LSM>= 10 kPa
- Age >= 18 years old
- Sufficient digital literacy or supported from a caregiver with sufficient digital literacy
- Smartphone (Android or iOS) able to download and run the App
- Able to understand and communicate in Italian
- Able to sign the informed consent
Who cannot join
- Major psychiatric disorder
- Not able to use digital technologies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD
Rome, Lazio, 00168
Luca Miele, +390630155701, luca.miele@policlinicogemelli.it
Luca Miele
About this study
The prevalence of Metabolic dysfunction-associated steatotic liver disease (MASLD) and its severe form, Metabolic dysfunction-associated steatohepatitis (MASH), is high and they are increasingly becoming major causes of cirrhosis, hepatocellular carcinoma (HCC), and the need for liver transplantation. Due to the lack of noticeable symptoms during the early stages, the detection of MASLD is often delayed until the disease has advanced.
Currently, the treatment options MASLD are limited to lifestyle interventions such as dietary changes and physical activity. Despite the increasing prevalence of MASLD, there are no drugs available on the market specifically for this condition.
Read more
The goal is to made new model care which integrates the standard clinical procedures with a digital approach, namely a mobile application for patients and a clinical dashboard for healthcare professionals (HCPs), integrated with simple clinical data (anthropometric, laboratory and imaging data).
This study wants to test the feasibility of integrating a digital intervention to improve the patient engagement and linkage to care in order to identify the advanced MASLD at earliest stage (secondary prevention) and mitigate the impact of ongoing advanced liver disease helping patients to manage the long-term effect of disease.
To achieve this goal the study will leverage on a mobile app named OpenTele in order to test the adherence to lifestyle changes in patient with MASLD and on the connected clinical dashboard.
The app aims at integrating the standard clinical practice with digital technologies able to guide and support patients in order to seamlessly integrate secondary prevention strategies in their everyday life with 2 main aims:
- to implement a strategy for delay progression of liver disease;
- to reduce the effect of cirrhosis (tertiary prevention).
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
App Adherence (>80% over 4 weeks)
Assessed via smartphone (number of app access)
Measured: 4 weeks
Secondary outcomes (6)
Weight reduction assessment
Number of subjects with a 12-month reduction between 7-10% of weight compared to baseline
Measured: 12 month
Change in liver and spleen stiffness
Assessed by transient elastography
Measured: Baseline, after 4 weeks and 12 month
Change in Patient Reported Outcome questionnaire
Evaluation of overall physical well-being through the administration of questionnaires
Measured: 12 weeks
Changes in measure energy expenditure
Cycle ergometer
Measured: 12 month
Microbiome signature
Analysis of microbiome signature from feces
Measured: 12 month
Clinical events
Record of number of hospitalization, decompensation, variceal bleeding, encephalopathy, ascites, liver cancer, liver transplantation, death
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start16 Jan 2025
- Primary completion14 Dec 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
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 Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Miele, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879236
- Sponsor's protocol ID
- 6618
- Acronym
- CALIBRE
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease
- ClinicalTrials.gov ID
- NCT06879236
- Acronym / sponsor ID
- CALIBRE / 6618
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 17 Mar 2025 (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 prevalence of Metabolic dysfunction-associated steatotic liver disease (MASLD) and its severe form, Metabolic dysfunction-associated steatohepatitis (MASH), is high and they are increasingly becoming major causes of cirrhosis, hepatocellular carcinoma (HCC), and the need for liver transplantation. Due to the lack of noticeable symptoms during the early stages, the detection of MASLD is often delayed until the disease has advanced.
Currently, the treatment options MASLD are limited to lifestyle interventions such as dietary changes and physical activity. Despite the increasing prevalence of MASLD, there are no drugs available on the market specifically for this condition.
The goal is to made new model care which integrates the standard clinical procedures with a digital approach, namely a mobile application for patients and a clinical dashboard for healthcare professionals (HCPs), integrated with simple clinical data (anthropometric, laboratory and imaging data).
This study wants to test the feasibility of integrating a digital intervention to improve the patient engagement and linkage to care in order to identify the advanced MASLD at earliest stage (secondary prevention) and mitigate the impact of ongoing advanced liver disease helping patients to manage the long-term effect of disease.
To achieve this goal the study will leverage on a mobile app named OpenTele in order to test the adherence to lifestyle changes in patient with MASLD and on the connected clinical dashboard.
The app aims at integrating the standard clinical practice with digital technologies able to guide and support patients in order to seamlessly integrate secondary prevention strategies in their everyday life with 2 main aims:
- to implement a strategy for delay progression of liver disease;
- to reduce the effect of cirrhosis (tertiary prevention).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with type 2 diabetes and/or metabolic syndrome and/or dyslipidemia and/or obesity (BMI>30 Kg/m2) and/or familiar history for cirrhosis or liver cancer in the absence of known risk factors
Key inclusion criteria (6 listed)
- Diagnosed with MASLD and LSM>= 10 kPa
- Age >= 18 years old
- Sufficient digital literacy or supported from a caregiver with sufficient digital literacy
- Smartphone (Android or iOS) able to download and run the App
- Able to understand and communicate in Italian
Key exclusion criteria (2 listed)
- Major psychiatric disorder
- Not able to use digital technologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
App Adherence (>80% over 4 weeks)
Time frame: 4 weeks
Assessed via smartphone (number of app access)
6 secondary outcomes
Weight reduction assessment
Time frame: 12 month
Change in liver and spleen stiffness
Time frame: Baseline, after 4 weeks and 12 month
Change in Patient Reported Outcome questionnaire
Time frame: 12 weeks
Changes in measure energy expenditure
Time frame: 12 month
Microbiome signature
Time frame: 12 month
Clinical events
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Related trials for NASH
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
Luca Miele principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NASH and NAFLD, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Miele (+390630155701, luca.miele@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App Adherence (>80% over 4 weeks) (time frame: 4 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 17 Sep 2026.