Skip to main content
Indiana University School of Medicine
Indiana University School of Medicine
Department of Medicine
Physician-scientists at IU School of Medicine conduct ground-breaking research to understand metabolic dysfunction-associated steatotic liver disease (MASLD), and metabolic dysfunction-associated steatohepatitis (MASH).

Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a common liver condition linked to obesity, diabetes, high blood pressure, and high cholesterol — affecting people who consume little or no alcohol. It impacts over 100 million U.S. adults, or about 1 in 3. Obesity is the leading cause, with studies suggesting fatty liver is present in up to two-thirds of obese adults and half of obese children.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) is a more advanced form of MASLD, marked by liver inflammation and damage. The exact cause of MASH is still being studied, but it likely involves a mix of oxidative stress, inflammatory signals from fat and immune cells, liver cell death, inflammation in fat tissue, and disruptions in gut bacteria that may worsen liver injury.

Investigators

4910-Chalasani, Naga Naga P. Chalasani, MD

Naga P. Chalasani, MD

David W. Crabb Professor of Gastroenterology and Hepatology

42036-Desai, Archita Archita Desai, MD

Archita Desai, MD

Assistant Professor of Medicine

5172-Gawrieh, Samer Samer Gawrieh, MD

Samer Gawrieh, MD

Professor of Clinical Medicine

5166-Orman, Eric Eric Orman, MD

Eric Orman, MD

Associate Professor of Medicine

4674-Samala, Niharika Niharika Samala, M.D.

Niharika Samala, M.D.

Assistant Professor of Medicine

5034-Vuppalanchi, Raj Raj Vuppalanchi, M.D.

Raj Vuppalanchi, M.D.

Professor of Medicine

Open Research Studies for MASLD

Fatty Liver Clinic

Enrolling: Yes

Principle Investigator: Niharika Samala, MD

Duration: 1 visit - window of up to 3 years

Patient Population: Adults with MASLD.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

HIV Fatty Liver

Enrolling: Yes

Principle Investigator: Samer Gawrieh, MD

Duration: 1 visit

Patient Population: Adults with HIV and fatty liver.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

HIV Liver Biopsy

Enrolling: Yes

Principle Investigator: Samer Gawrieh, MD

Duration: 1 visit

Patient Population: HIV infected individuals with MASLD.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Vitamin E Dosing Study (VEDS): A dose-finding clinical trial of vitamin E for the treatment of adult MASLD

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: 126 weeks total: Recruitment Phase is 72 weeks; Follow-up Phase is 48 weeks

Patient Population: The study population will be 200 adults age 18 years or older with MASLD located in the United States. FibroScan CAP>280 dB/m; Serum alanine aminotransferase (ALT) ≥ 60 U/L.

Drug(s): Participants will be given 133.4 mg (200 IU), 266.8 mg (400 IU), or 533.6 mg (800 IU) of vitamin E or a matching placebo.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

A Single-Ascending and Repeated Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3849891 in Participants with Metabolic Dysfunction-Associated Steatotic Liver Disease who have the PNPLA3 I148M Genotype

Enrolling: Yes

Principle Investigator: Niharika Samala, MD

Duration: This is a 2-part study to explore safety, tolerability, PK, and PD of LY3849891.

  • Part A: Up to 32 weeks; Screening is approximately 42 days; Inpatient treatment phase 5 days followed by 26 weeks follow-up period
  • Part B: Up to 32 weeks;  Screening is approximately 42 days; Treatment period: 5 weeks; 2 Inpatient treatments of 5 days; Outpatient follow-up period, up to 26 weeks

Patient Population: Adult participants with MASLD who have the PNPLA3 I148Mallele(s); either homozygous or heterozygous.  Approximately 176 subjects, ages 18 to 70, will be enrolled in this multi-site study.

Drug(s): Double-blinded dose of LY3849891 or placebo by subcutaneous injection

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

Global Longitudinal Assessment of Metabolic Dysfunction-Associated Steatotic Liver Disease using Magnetic Resonance Elastography

Enrolling: Yes

Principle Investigator: Raj Vuppalanchi, MD

Duration: Up to 10 years, minimum of 4 years; once a year visit

Patient Population: Adult patients with biopsy proven (or pending) MASLD/MASH related cirrhosis.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Database 3

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: Recruitment: At least 240 weeks. Follow-up: At least 48 weeks.

Patient Population: 2230 patients age 2 years or older with histologically confirmed MASLD or MASH located in the United States. 1,500 patients 18 years and older at the time of enrollment. 750 patients 2 years or older and up to 17 years old at the time of enrollment.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

Open Research Studies for MASH

HIV MASH

Enrolling: Yes

Principle Investigator: Samer Gawrieh, MD

Duration: 1 visit per month / 6 months

Patient Population: Adults with HIV, MASH and hepatic fibrosis

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

Target MASH

Enrolling: No

Principle Investigator: Niharika Samala, MD

Duration: 5 years

Patient Population: Adults ages 18 and up being treated for MASLD or MASH, no simultaneous enrollment in to MASH trials.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

Phase 2b Study of GSK4532990 in Adults with MASH (HORIZON)

Enrolling: No

Principle Investigator: Niharika Samala, MD

Duration: 52 weeks

Patient Population: Patients diagnosed with MASH.

Drug(s): GSK4532990

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

Non-invasive quantification of liver health in MASH

Enrolling: Yes

Principle Investigator: Raj Vuppalanchi, MD

Duration: 1 visit (2-6 weeks before or after liver biopsy)

Patient Population: Adult patients with biopsy proven (or pending) MASLD or MASH related cirrhosis.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Metabolic Dysfunction-Associated Steatohepatitis and Fibrosis

Enrolling: No

Principle Investigator: Samer Gawrieh, MD

Duration: 89 weeks

Patient Population: MASH with F2 and F3 fibrosis

Drug(s): Saroglitazar Magnesium

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

Closed MASLD and MASH Studies

Enrolling: No

Duration: 1 visit

Patient Population: Adults age 40-75 who have recent liver biopsies with the results in the following cohorts: Absence of NAFLD, Early Stage MASLD, MASH with no fibrosis, NASH with fibrosis stages 1 - 3.

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: 23 week study period

Patient Population: MASH patients with Fibrosis Stage 1-3 and Homozygous for PNPLA3 148M Risk Allele.

Drug(s): Az2693 SQ Injection

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: 23 week study period

Patient Population: MASH patients with Fibrosis Stage 1-3 and Homozygous for PNPLA3 148M Risk Allele.

Drug(s): Az2693 SQ Injection

View this study on clinicaltrials.gov

Enrolling: No

Principle Investigator: Niharika Samala, MD

Duration: 24 weeks

Patient Population: Biopsy-confirmed MASH F1 to F3 patients (historical biopsies performed within the last 12 months prior to screening) or participants with clinical characteristics or biomarkers suggestive of MASH.

Drug(s): AZD7503 or placebo

View this study on clinicaltrials.gov

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: 1 year

Patient Population: F2 - F3

Drug(s): Terzepatide

View this study on clinicaltrials.gov

Enrolling: No

Principle Investigator: Naga Chalasani, MD

Duration: Interventional study portion - 72 weeks.

Patient Population: HIV+ Drug(s): Saroglitazar

View this study on clinicaltrials.gov

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: 6-8 years

Patient Population: Adults with NASH, fibrosis stage 2-3.

Drug(s): Obeticholic Acid tablet or placebo

Enrolling: No

Principle Investigator: Eric Orman, MD

Duration: 24 weeks

Patient Population: Adults with MASH and Type 2 Diabetes Mellitus

Drug(s): IVA337 (Lanifibranor)andEmpagliflozin (Jardiance)

View this study on clinicaltrials.gov

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: 16 weeks

Patient Population: Noncirrhotic adults with MASH

Drug(s): TERN-501, a thyroid hormone receptor-β (THR-β) agonist, and TERN-101, a farnesoid X receptor (FXR) agonist

View this study on clinicaltrials.gov