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Liver Disease Study - Oral Drug

We are studying a new drug called denifanstat to see if it can help treat metabolic liver disease (MASLD) and its more serious form, MASH. They also want to see how safe this drug is for people to use. This study will test whether denifanstat can stop fat buildup and liver scarring by blocking certain processes in the body that cause these problems.

Age & Gender

  • 18 years ~ 75 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

If you decide to participate in this study, there are a few key things we'll ask you to do: Study Visits: You'll visit the study site about 7 times over the course of a year. During these visits, we'll check on your health, take blood samples, perform some routine testing on your liver and eyes and ask about any side effects or changes in your medications. Take Study Medication: You'll take either the study drug (denifanstat) or a placebo (a pill with no active ingredient) once a day for 52 weeks. Complete Questionnaires: We'll ask you to fill out surveys and keep track of certain information in an electronic diary (eDiary) to help us understand how the treatment affects your daily life and well-being. Follow-up: After you complete the treatment phase, there will be one follow-up visit about 4 weeks later. We'll guide you through each step and provide regular check-ins to monitor your progress. You can withdraw from the study at any time if you choose to.

Incentives

Information provided upon request, Liver scans, eye exams

In-person visits:
9
Phone or online visits:
6
Total length of participation:
About 1 year

Looking for Specific Volunteers

Able to participate:

  • metabolic liver disease (MASLD) Or Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Not eligible if:

  • None

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

A Barritt
Center for Gastrointestinal Biology and Disease

Study Type

Clinical or Medical
Interventional

Study Topics

Stomach, Digestion and Gut Health
Eating, Nutrition, and Metabolism
Kidneys and Liver

IRB Number

24-2677

ClinicalTrials.gov

Not yet available

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