Clinical trial Recruiting at 2 sites Observational Ages 18 to 75

Patients' perspectives and needs in metabolic dysfunction‑associated steatohepatitis

Official title: Perspectives on the Multidisciplinary Approach to Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study With Patients From the MASH-Cardiovascular Programme at Hospital de Sant Pau i la Santa Creu, Barcelona

Run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT07188220 · Data updated 2026-11-12

This study will see what adults with MASH expect, need, and feel about their care before and after taking part in a cardiovascular health program in Barcelona.

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment25 (estimated)
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Academic / other
Locations2 sites (Barcelona and 1 other locations)
StatusRecruiting
StartedJune 3, 2025
Main results expectedDecember 20, 2027
Study endsJanuary 20, 2028
Registry record updatedSeptember 23, 2025
Trial IDNCT07188220 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 18–75 with MASH and fibrosis stage F2–F4 (BMI ≥27 kg/m²) who are enrolled in and willing to be interviewed before and after the MASH-Cardiovascular Programme at Hospital de Sant Pau.

Probably not a fit

Patients unlikely to benefit include those not enrolled in the program or those with exclusion conditions such as decompensated cirrhosis, eGFR <30 mL/min, type 1 diabetes, heavy alcohol use, malnutrition, or dietary restrictions that prevent program participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational qualitative study conducts two semi-structured interviews with patients diagnosed with metabolic dysfunction‑associated steatohepatitis (MASH): one before and one after their participation in the MASH-Cardiovascular Programme at Hospital de la Santa Creu i Sant Pau in Barcelona. Participants are adults aged 18–75 with fibrosis stage F2–F4 and BMI ≥27 kg/m² who are followed in the hospital’s hepatology/gastroenterology clinic and who consent to the interviews. Interview topics include expectations, attitudes, knowledge, needs, and perceived barriers to MASH management and lifestyle change. Study team members will analyze transcripts to identify common themes that could inform patient-centered care and program improvements.

Why it matters

Potential benefit: If successful, the findings could help tailor the MASH-Cardiovascular Programme and other care pathways to better meet patients’ needs and improve engagement.

How similar studies have gone: Previous qualitative studies of NAFLD/MASH patient experiences have provided useful insights for care design, but pre‑and‑post interviews tied to a specific cardiovascular program are less commonly reported.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients who voluntarily agree to participate in the MASH-Cardiovascular Programme.
* Patients followed in the outpatient hepatology/gastroenterology clinic at Hospital de Sant Pau with a diagnosis of MASH and fibrosis stage F2-F4.
* Patients aged between 18 and 75 years.
* Patients with a BMI ≥ 27 kg/m².
* Patients who consent to participate in the study-specific interviews.

Exclusion Criteria:

* Patients who do not agree to participate in the study-specific interviews.
* Patients meeting exclusion criteria of the MASH-Cardiovascular Programme:
* Patients with decompensated liver cirrhosis.
* Patients who are vegetarians or have dietary habits/preferences that prevent adherence to standard-of-care nutritional guidelines.
* Patients with moderate-to-severe alcohol consumption (\>20 g/day for women and \>40 g/day for men).
* Patients with an eGFR \< 30 mL/min.
* Patients with malnutrition.
* Patients with type 1 diabetes or other forms of diabetes.
* Patients who are candidates for bariatric surgery.
* Patients with active malignancy.
* Patients with advanced or unstable heart failure.
* Patients with eating disorders or severe psychiatric illness.
* Patients currently enrolled in another clinical trial.
* Pregnant women or women planning to become pregnant.

Where it's running

  • IR Sant Pau
    Barcelona, Spain
    Recruiting
  • IR Sant Pau
    Barcelona, Spain
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Pemvidutide for noncirrhotic MASH: a phase 3 study

    This phase 3 study tests pemvidutide versus placebo in adults with noncirrhotic MASH to see if it improves liver health and safety.

    Recruiting at 9 sites Phase 3 Altimmune, Inc. · North Little Rock, Arkansas and 8 other locations · NCT07795164

  • VV-14303 for metabolic liver disease in adults with MASH

    This study tests VV-14303, a gene therapy, in adults with metabolic dysfunction-associated steatohepatitis (MASH) to see if it is safe and how well it works.

    Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Chandler, Arizona and 2 other locations · NCT07732400

  • HRS-4729 and HRS9531 injections in adults with MASH

    This study tests whether HRS-4729 and HRS9531 injections (and their placebos) can help adults with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.

    Recruiting at 2 sites Phase 2 Fujian Shengdi Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07660848

  • Gut microbiota–derived amino acid metabolites in MASLD/MASH

    This study tests whether gut microbiota–produced amino acid metabolites are linked to MASLD/MASH in adults by collecting stool, blood, and urine samples and analyzing dietary factors.

    Recruiting Hospices Civils de Lyon · Pierre-Bénite · NCT07313007

  • UBT251 treatment for metabolic dysfunction-associated steatohepatitis (MASH)

    This trial will test whether daily UBT251 (2 mg, 4 mg, or 6 mg) for 48 weeks helps adults with biopsy-confirmed MASH and moderate fibrosis compared with placebo.

    Recruiting Phase 2 The United Bio-Technology (Hengqin) Co., Ltd. · Beijing, Beijing Municipality · NCT07145151

  • Testing Survodutide for Liver Disease in Patients with NASH/MASH

    This study is testing a new medication called survodutide to see if it can help adults with liver disease related to metabolic dysfunction feel better and improve their liver health.

    Recruiting at 497 sites Phase 3 Boehringer Ingelheim · Birmingham, Alabama and 531 other locations · NCT06632444

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.