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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

4910-Chalasani, Naga

Naga P. Chalasani, MD

Interim Chair, Department of Medicine

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5172-Gawrieh, Samer

Samer Gawrieh, MD

Associate Professor of Clinical Medicine

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4674-Samala, Niharika

Niharika Samala, MBBS

Assistant Professor of Medicine

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42036-Desai, Archita

Archita Desai, MD

Assistant Professor of Medicine

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5166-Orman, Eric

Eric Orman, MD

Assistant Professor of Medicine

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5034-Vuppalanchi, Raj

Raj Vuppalanchi, MB,BS

Professor of Medicine

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Open Research Studies for Non-alcoholic Fatty Liver Disease

DSM NAFLD

Enrolling: Yes

Principle Investigator: Naga Chalasani, MD

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

Interested in this study? Please contact the coordinator below:
Stacey Richardson
stlyrich@iu.edu
(317) 278-9215

View the study on clinicaltrials.gov

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 coordinator below:
Emily Smith
es37@iu.edu
(317) 274-1692

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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 coordinator below:
Montreca Robison
mgrobiso@iu.edu
(317) 278-0408

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 coordinator below:
Montreca Robison
mgrobiso@iu.edu
(317) 278-0408

Mitochondrial Respiration in People with NAFLD and Cirrhosis

Enrolling: Yes

Principle Investigator: Eric Orman, MD

Duration: 1 time visit

Patient Population: Patients with NASH who have had a biopsy within 3 years.

Interested in this study? Please contact the coordinator below:
Jessie Vaughn
jevaugh@iu.edu
(317) 274-8427

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 coordinator below:
Jessie Vaughn
jevaugh@iu.edu
(317) 274-8427

View the study on clinicaltrials.gov

Post-Transplant NAFLD

Enrolling: Yes

Principle Investigator: Niharika Samala, MBBS

Duration: 1 visit

Patient Population: Post-transplant patients.

Interested in this study? Please contact the coordinator below:
Brandon Wind
bewind@iu.edu
(317) 278-6222

Progenity

Enrolling: Yes

Principle Investigator: Naga Chalasani, MD

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.

Interested in this study?Please contact the coordinator below:
Emily Smith
es37@iu.edu
(317) 274-1692

Viking

Enrolling: Yes

Principle Investigator: Samer Gawrieh, MD

Duration: 1 year

Patient Population: F1-F3, NAS > 4

Drug: Novel drug VX2809

Interested in this study? Please contact the coordinator below:
Stacey Richardson
stlyrich@iu.edu
(317) 278-9215

Open Research Studies for Nonalcoholic Steatohepatitis

Axcella

Enrolling: Yes

Principle Investigator: Archita Desai, MD

Duration: 20 weeks

Patient Population: Patients with mild to moderate hepatic insufficiency.

Drug(s): Amino Acid supplement

Interested in this study? Please contact the coordinators below:
Logan Hobbs

lshobbs@iu.edu
(317) 274-8422

View the study on clinicaltrials.gov

AZ - Phase 1 D7830C00002

Enrolling: TBD

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 coordinator below:
Lisa Garrison
ljgarris@iu.edu
(317) 278-3206

Phase 1b Covance Galecto

Enrolling: TBD

Principle Investigator: Raj Vuppalanchi, MD

Duration: 6 week study period

Patient Population: Patients with NASH fibrosis

Drug(s): Oral GB1211

Interested in this study? Please contact the coordinator below:
Holly King
hrking1@iu.edu
(317) 278-6200

Eli Lilly

Enrolling: Yes

Principle Investigator: Raj Vuppalanchi, MD

Duration: 1 year

Patient Population: F2-3

Drug(s): Terzepatide

Interested in this study? Please contact the coordinator below:
Holly King
hrking1@iu.edu
(317) 278-6200

Galmed

Enrolling: Yes

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

Interested in this study? Please contact the coordinator below:
Lisa Garrison
ljgarris@iu.edu
(317) 278-3206

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 coordinator below: 
Montreca Robison
mgrobiso@iu.edu
(317) 278-0408

HIV NASH CRN

Enrolling: TBD

Principle Investigator: Naga Chalasani, MD

Duration: Interventional study portion - 72 weeks.

Patient Population: HIV+

Drug(s): TBD

Interested in this study? Please contact the coordinator below:
Holly King
hrking1@iu.edu
(317) 278-6200

Intercept 303 - NASH

Enrolling: Yes

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 coordinator below:
Holly King
hrking1@iu.edu
(317) 278-6200

Novo Nordisk

Enrolling: Yes

Principle Investigator: Raj Vuppalanchi, MD

Duration: 1 year

Patient Population: Cirrhotic

Drug(s): Semiglutide

Interested in this study? Please contact the coordinator below:
Holly King
hrking1@iu.edu
(317) 278-6200

Target NASH

Enrolling: Yes

Principle Investigator: Niha 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 coordinator below:
Emily Smith
es37@iu.edu
(317) 274-1692

TERN/Lift Trial

Enrolling: TBD

Principle Investigator: Raj Vuppalanchi, MD

Duration: 16 week study period

Patient Population: Ages 18-75 diagnosed with NASH.

Drug(s): Oral TERN-101

Interested in this study? Please contact the coordinator below:
Jessie Vaughn

jevaugh@iu.edu

(317) 274-8427

Closed Non-alcoholic Fatty Liver Disease Studies

  • 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

  • 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