Fibrosis Lessens After Metabolic Surgery
Recruiting · 22 sites across 4 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment. Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •You are a candidate for general anesthesia.
- •You are eligible for metabolic surgery (RYGB or SG) based on the ASMBS/IFSO 2022 guidelines.
- •You are insured for metabolic surgery (requirements may vary by country).
- •You are between 18 and 75 years old when you sign the consent.
- •You have MASH with liver fibrosis (F1–F4 on baseline biopsy) and meet the study’s liver-scarring criteria (like FIB-4 ≥ 1.3 and at least one advanced-fibrosis measure such as FibroScan® LSM ≥ 12 kPa).
🚫 You may not be able to join if…
- •You have a known history of other chronic liver diseases such as hepatitis B (HBsAg positive), hepatitis C (HCV RNA positive), autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson’s disease, alpha-1-antitrypsin deficiency, hemochromatosis, drug-induced liver disease, bile duct obstruction, or suspected/proven liver cancer.
- •Your weight changed by more than 10% in the 6 months before the first study visit (or before a historical liver biopsy).
- •You took semaglutide, tirzepatide, or liraglutide within 90 days before the first study visit (with limited exceptions described).
- •You have type 1 diabetes or autoimmune diabetes.
- •You are pregnant or breastfeeding (or you cannot/will not use reliable contraception).
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults 18–75 years old who are being evaluated for metabolic surgery (RYGB or SG)
- ✓BMI 35–70 kg/m² and evidence of advanced liver fibrosis (FIB-4 ≥1.3 plus imaging/biomarker thresholds)
- ✓Can safely undergo general anesthesia and comply with study procedures (including liver biopsies)
- ✓Can use reliable contraception for 2 years (if able to become pregnant) and is not pregnant/breastfeeding
- ✓Obesity with NASH/MASH; advanced fibrosis but without other chronic liver diseases or prior bariatric surgery
- ✓If you have type 2 diabetes, meds must be stable (and not include recent semaglutide/tirzepatide/liraglutide) with HbA1c ≤12%
- !Some conditions may not be a fit: Fatty liver disease (NASH/MASH), Heart / cardiovascular disease, High blood pressure, Kidney disease, COPD (chronic lung disease)
- !Not for people who are pregnant or breastfeeding
- !May require a break from current GLP-1 medications
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 2 groups in this study.
What to expect, step by step
· This study lasts about 104 weeks (~24 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 104 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Procedure: Metabolic surgery
- Drug: Incretin-Based Therapy
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
Ali Aminian
Overseen by Ali Aminian, MD
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma.
Is it safe? Who makes sure of that?+
This is a study of an already-approved treatment (Phase 4). Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
I take a GLP-1 medication (like Ozempic or Wegovy). Can I still join?+
Maybe. This study may ask you to pause certain weight or diabetes medications for a period of time (a 'washout') before joining, or it may be looking for people not currently on them. The coordinator will review your medications with you — don't stop any medication on your own.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. This study may also compensate you for your time and travel — the team will tell you the amount before you join. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06374875 · Locations: Arizona · Indiana · Minnesota · Ohio