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

Investigators

Open Research Studies for Non-alcoholic Fatty Liver Disease

Naga P. Chalasani, MD

David W. Crabb Professor of Gastroenterology and Hepatology

Archita Desai, MD

Assistant Professor of Medicine

Samer Gawrieh, MD

Professor of Clinical Medicine

Eric Orman, MD

Associate Professor of Medicine

Niharika Samala, MD

Assistant Professor of Medicine

Raj Vuppalanchi, MD

Professor of Medicine

Fatty Liver Clinic

Enrolling: Yes

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

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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 NAFLD

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

NAFLD Database 2 (NASH CRN)

Enrolling: Yes Principle Investigator: Raj Vuppalanchi, MD

Duration: 5 - 10 years

Patient Population: Adult patients with suspected or known non-alcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH)-related cirrhosis of the liver.

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

View the study on clinicaltrials.gov

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

Enrolling: Yes

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

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 Nonalcoholic Fatty 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 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

View the study on clinicaltrials.gov

Global Longitudinal Assessment of Nonalcoholic Fatty Liver Disease (NAFLD) 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) NAFLD/NASH related cirrhosis.

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

Open Research Studies for Nonalcoholic Steatohepatitis

AZ - Phase 1 D7830C00002

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

A Phase I randomized single-blind placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of AZD7503 following multiple ascending dose administration to patients with suspected non-cirrhotic non-alcoholic steatohepatitis (NASH)

Enrolling: No

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

View the study on clinicaltrials.gov

HIV NASH

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

View the study on clinicaltrials.gov

HIV NASH CRN

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

View the study on clinicaltrials.gov

Target NASH

Enrolling: No

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

A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of Lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with Non-alcoholic steatohepatitis (NASH) and type 2 Diabetes mellitus (T2DM)

Enrolling: Yes

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

View the study on clinicaltrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)

Enrolling: No

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

View the study on clinicaltrials.gov

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

Enrolling: Yes

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

View the study on clinicaltrials.gov

Non-invasive quantification of liver health in NASH

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) NAFLD or NASH 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 Nonalcoholic Steatohepatitis and Fibrosis

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

View the study on clinicaltrials.gov

Intercept 303 - NASH

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

Eli Lilly

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

Closed Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis Studies

Progenity

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 NAFLD, NASH with no fibrosis, NASH with fibrosis stages 1 - 3.

Bristol-Myers Squibb NASH Study

Enrolling: No

Duration: 1 year; 16 weeks on treatment

Primary Outcomes Measured: Change in percent hepatic fat fraction (%) by Magnetic Resonance Imaging

Drug(s): BMS-986036, daily subcutaneous injection
DSM NAFLD

Enrolling: No

Duration: 6 months

Patient Population: F1-F3, ALT >45, no Vitamin E or Fish Oil - 3 months prior to randomization

Drug(s): Vitamin E and Fish Oil

Clinicaltrials.gov
Eli Lilly

Enrolling: No

Duration: 1 year

Patient Population: F2-3

Drug(s): Terzepatide
Fibroscan with CAP

Enrolling: No

Duration: 1 visit
Galectin GT_026 the NASH-CX Trial

Enrolling: No

Duration: 67 weeks

Primary Outcomes Measured: Evaluate the efficacy of GR-MD-02 on reducing hepatic venous pressure gradient (HVPG) as a measure of portal pressure compared to placebo

Drug(s): GR-MD-02 in 2mg/kg body weight or 8mg/kg body weight or placebo

Clinicaltrials.gov
Gilead GS-US-384-1497 NASH Study

Enrolling: No

Duration: 36 weeks

Primary Outcomes Measured: The study evaluated the safety and tolerability of GS-4997 alone or in combination with Simtuzumab (SIM) in adults with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3.

Drug(s): GS-4997 alone or in combination with Simtuzumab

Clinicaltrials.gov
NuSirt Non-alcoholic Fatty Liver Disease

Enrolling: No

Duration: 18 weeks

Primary Outcomes Measured: The change in hepatic fat.

Drug(s): Fixed-dose Leucine, Metformin, Sildenafil combinations (NS-0200) or placebo, capsules twice a day

Clinicaltrials.gov
Novo Nordisk

Enrolling: No

Principle Investigator: Raj Vuppalanchi, MD

Duration: 1 year

Patient Population: Cirrhotic

Drug(s): Semiglutide
Intercept 303 - NASH

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
Galmed

Enrolling: No

Principle Investigator: Samer Gawrieh, MD

Duration: 5-7 years

Patient Population: Adults with NASH and fibrosis who are overweight/obese and have pre-diabetes or type 2 diabetes.

Drug(s): Aramchol 300mg by mouth twice daily or placebo
Viking

Enrolling: No
Principle Investigator: Samer Gawrieh, MD

Duration: 1 year

Patient Population: F1-F3, NAS > 4

Drug: Novel drug VX2809

Clinicaltrials.gov
Velacur (NAFLD)

Enrolling: No
Principle Investigator: Samer Gawrieh, MD

Duration: 5 years

Patient Population: 21+ with diagnosis of NAFLD/NASH and biopsy within 6 months of visit

Clinicaltrials.gov
Post-Transplant NAFLD

Enrolling: No
Principle Investigator: Niharika Samala, MD

Duration: 1 visit

Patient Population: Post-transplant patients.
Axcella

Enrolling: No
Principle Investigator: Archita Desai, MD

Duration: 20 weeks

Patient Population: Patients with mild to moderate hepatic insufficiency.

Drug(s): Amino Acid supplement

Clinicaltrials.gov