Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis

Non-alcoholic fatty liver disease (NAFLD) is the buildup of fat in the liver that is not caused by drinking too much alcohol. People who have it do not have a history of heavy drinking. NAFLD is closely related to being overweight.

Nonalcoholic Steatohepatitis (NASH) is a form of nonalcoholic fatty liver disease (NAFLD) in which you have hepatitis—inflammation of the liver—and liver cell damage, in addition to fat in your liver. Inflammation and liver cell damage can cause fibrosis, or scarring, of the liver

Principle Investigator: Niharika Samala, MD

Duration: 1 visit - window of up to 3 years

Patient Population: Adults with NAFLD.

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

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

Enrolling: Yes

Principle Investigator: Samer Gawrieh, MD

Duration: 1 visit

Patient Population: HIV infected individuals with NAFLD

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

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 NAFLD 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

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 NAFLD 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

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) NAFLD/NASH related cirrhosis.

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

Enrolling: Yes

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 NAFLD or NASH 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

Enrolling: Yes

Principle Investigator: Raj Vuppalanchi, MD

Duration: 23 week study period

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

Drug(s): Az2693 SQ Injection

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

Principle Investigator: Niharika Samala, MD

Duration: 24 weeks

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

Drug(s): AZD7503 or placebo

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

Enrolling: Yes

Principle Investigator: Samer Gawrieh, MD

Duration: 1 visit per month / 6 months

Patient Population: Adults with HIV, NASH and hepatic fibrosis

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

Enrolling: Yes

Principle Investigator: Naga Chalasani, MD

Duration: Interventional study portion - 72 weeks.

Patient Population: HIV+ Drug(s): Saroglitazar

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

Principle Investigator: Niharika Samala, MD

Duration: 5 years

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

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

Principle Investigator: Eric Orman, MD

Duration: 24 weeks

Patient Population: Adults with NASH and Type 2 Diabetes Mellitus

Drug(s): IVA337 (Lanifibranor) and Empagliflozin (Jardiance)

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

Principle Investigator: Raj Vuppalanchi, MD

Duration: 16 weeks

Patient Population: Noncirrhotic adults with NASH

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

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

Principle Investigator: Niharika Samala, MD

Duration: 52 weeks

Patient Population: Patients diagnosed with NASH.

Drug(s): GSK4532990

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

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) NAFLD or NASH related cirrhosis.

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

Enrolling: Yes

Principle Investigator: Samer Gawrieh, MD

Duration: 89 weeks

Patient Population: NASH with F2 and F3 fibrosis

Drug(s): Saroglitazar Magnesium

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

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

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

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: 1 year

Patient Population: F2 - F3

Drug(s): Terzepatide

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