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Available Clinical Research

Thank you for your interest in liver research at Penn State Health Liver Center and Penn State College of Medicine.

Dr. Jonathan Stine and his expert team are dedicated to improving outcomes for people with:

  • Nonalcoholic fatty liver disease
  • Liver cancer
  • Liver disease-related clotting disorders
  • Need for liver transplantation
  • And other liver conditions

Browse the sections below to learn more about clinical research with Dr. Stine’s team, or contact the team directly:

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Ongoing Studies

Open the tabs below to view all clinical research with Dr. Stine and his team. A brief overview of the study and criteria are included. For questions about what happens during liver research studies, please visit this page.

If you do not see your specific condition listed below or are interested in upcoming studies, you are invited to join a research registry. The research registry will ask you a few brief questions and collect your contact information so the study team can reach out if a study becomes available.

Join the registry here

Nonalcoholic Steatohepatitis (NASH) Clinical Trials Expand answer

AMPED

The purpose of this trial is to test different levels of exercise needed to reduce liver fat in patients with NASH.

Participants must be:

  • Diagnosed with a severe form of nonalcoholic fatty liver disease known as nonalcoholic steatohepatitis and have a liver biopsy proving NASH within six months of enrollment
  • Be age 18 to 69

View AMPED trial information on Studyfinder

Study contact:
Gloriany Rivas, BA, CCRC
Healthcare interpreter (Spanish)
grivas@pennstatehealth.psu.edu
717-531-0003, ext. 320223

Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial

This phase 2 trial will assess the safety and efficacy of three doses of NNC0194-0499 in combination with semaglutide versus placebo in the treatment of NASH.

Participants must be:

  • Diagnosed with a severe form of nonalcoholic fatty liver disease known as nonalcoholic steatohepatitis
  • Be ages 18 and older

View trial information on Studyfinder

Study contact:
Gloriany Rivas, BA, CCRC
Healthcare interpreter (Spanish)
grivas@pennstatehealth.psu.edu
717-531-0003, ext. 320223

ESSENCE

Nonalcoholic Steatohepatitis (NASH) is associated with increased risk of mortality. Currently, there are few treatment options. Therefore, there is a need for an effective and safe medication treatment options. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), can address certain aspects of NASH and is therefore considered a strong candidate for the treatment of NASH.

Participants must:

  • Be diagnosed with nonalcoholic steatohepatitis
  • Be ages 18 and older

View ESSENCE information on Studyfinder

Study contact:
Gloriany Rivas, BA, CCRC
Healthcare interpreter (Spanish)
grivas@pennstatehealth.psu.edu
717-531-0003, ext. 320223

Double Blind, randomized, placebo-controlled, multi-Center, study of AZD2693 in participants with NASH homozygous for PNPLA3 148M risk allele (Pending initiation)

The purpose of this voluntary research study is to test the safety and ability to tolerate of the an injection treatment of the study drug AZD2693 in patients with NASH.

Participants must be:

  • Diagnosed with a severe form of nonalcoholic fatty liver disease known as nonalcoholic steatohepatitis (NASH)
  • Be ages 18 to 65

View study information on Studyfinder

Study contact:
Gloriany Rivas, BA, CCRC
stinelab@pennstatehealth.psu.edu
717-531-0003, ext. 320223

NAVIGATE

This trial will evaluate the efficacy of belapectin in preventing the development of esophageal varices in NASH cirrhosis patients.

Participants must:

  • Be diagnosed with nonalcoholic steatohepatitis
  • Be ages 18 to 75
  • Be diagnosed with early stage cirrhosis
  • Be diagnosed with portal hypertension

View NAVIGATE information on Studyfinder

Study contact:
Gloriany Rivas, BA, CCRC
Healthcare interpreter (Spanish)
grivas@pennstatehealth.psu.edu
717-531-0003, ext. 320223

More nonalcoholic steatohepatitis (NASH) research studies

Additional studies are under review and will be accepting participants soon. Adults 18 and older with a diagnosis of nonalcoholic steatohepatitis (NASH) may be eligible.

Contact the study team to learn more:

Gloriany Rivas, BA, CCRC
Healthcare interpreter (Spanish)
grivas@pennstatehealth.psu.edu
717-531-0003, ext. 320223

Liver Cancer Clinical Trials Expand answer

There are currently no liver trials.

Portal Hypertension Clinical Trials Expand answer

PVCLD3

This is a prospective cohort study of subjects with portal hypertension to examine whether increased sphingosine 1 phosphate-to-ceramide ratio and circulating bile acids are associated with HPS in patients with advanced liver disease.

Patients must be:

  • Diagnosed with chronic portal hypertension
  • Able to have a referral for liver transplantation
  • 18 or older

Study contact:
Wes Heinle
jheinle@pennstatehealth.psu.edu
717-531-0003, ext. 321555

Autoimmune Biliary Trials Expand answer

RESPONSE

This is a Phase 3, international, multicenter evaluation of seladelpar in a randomized, double-blind, placebo-controlled, parallel-group study when administered for up to 12 months as a daily oral capsule in patients with PBC. Approximately 180 subjects will be randomized across approximately 150 sites worldwide.

Participants must be:

  • 18 to 75 years old
  • Diagnosed with primary biliary cholangitis: Two out of three of elevated ALP levels for 6 months or more, positive AMA and historical liver biopsy. (Liver biopsy on study is optional).
  • On ursodeoxycholic acid UDCA for at least 12 months prior to randomization or history of being intolerant to UDCA

View RESPONSE information on Studyfinder

Study contact:
Laurie Peiffer
lpeiffer@pennstatehealth.psu.edu
717-531-8259

More autoimmune biliary research studies

More studies are under review and will be accepting participants soon. Adults 18 and older with a diagnosis of primary biliary cholangitis (PBC) may be eligible.

Contact the study team to learn more:

Wes Heinle
jheinle@pennstatehealth.psu.edu
717-531-0003, ext. 321555

Completed Studies Expand answer

ELATIVE

A double-blind, randomized, placebo-controlled study and open-label long term extension to evaluate the efficacy and safety of elafibranor 80mg in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA).

EXALT

This trial aimed to help better understand how exercise impacts patients with liver cancer in order to identify treatments that can improve outcomes and access to liver transplantation.

Mobile-delivered lifestyle intervention program in patients with NASH

Participants were given access to the Noom Healthy Weight application for 16 weeks in order to evaluate the app’s impact on weight loss in nonalcoholic steatohepatitis (NASH) patients.

NASHFIT

This trial examined whether diet and exercise can improve nonalcoholic steatohepatitis (NASH) and the associated increase risk of clotting.

PIVOT

This research was conducted to prevent portal vein thrombosis (PVT) in patients with cirrhosis at risk for PVT by pharmacologic prophylaxis with intravenous antithrombin (AT-III).

PRIMIS

This study tested an investigational drug called GS-9674 in non-cirrhotic adults with primary sclerosing cholangitis (PSC) to see if it can potentially slow the progression of liver scarring (fibrosis) caused by PSC.

TARGET-HCC

This was a longitudinal, observational study of patients being managed for hepatocellular carcinoma (HCC) in usual clinical practice. TARGET-HCC aimed to create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

PROC-BLEED

The goal of this study was to obtain more knowledge regarding risk factors for procedural related bleeding in patients with cirrhosis.

Those interested in the results of studies should contact the Stine team:

Phone: 717-531-0003, ext. 320223
Fax: 717-531-6848
Email: StineLaboratory@pennstatehealth.psu.edu

COVID-19 Information

Penn State Health Liver Center has taken several steps to keep research participants safe.

This includes:

  • Conducting research visits remotely (from home) when possible
  • Practicing social distancing and using appropriate personal protective equipment (masks, face shields, gloves) during in-person research visits
  • Screening prior to all in-person research visits, including temperature checks for all employees and participants
  • Sanitation of all research spaces and equipment

Hear from Other Participants

Dr. Stine and his team smile with Bryan Boyer, a clinical trial participant

Dr. Stine and his team smile with Bryan Boyer, a clinical trial participant

“For as much as its [clinical trial participation] helped me so far, I’m sure it’s helping other people.”

Bryan Boyer was a participant in the NASHFit clinical trial with Dr. Stine’s team after he received a diagnosis for stage three nonalcoholic fatty liver disease.

Faced with the possibility of cirrhosis and a lifesaving liver transplant, which his sister had required, he decided to participate in NASHFit, a clinical study that aims to improve fatty liver disease using diet and exercise.

Watch Bryan’s story here >