Tulane GI and Liver Research

Akero AK-US-001-0107 (Synchrony Histology): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic, Nonalcoholic Steatosis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

This is a clinical trial for adults with non-cirrhotic nonalcoholic steatohepatitis (pronounced stee-AH-toe-hep-uh-TIE-tus), or NASH for short. The study will test an investigational drug called efruxifermin (EFX) to see whether it helps slow or possibly reverse fibrosis (scarring of the liver) and to learn about any side effects. 

You may be able to join the SYNCHRONY Histology study if you:

• Are from 18 to 75 years old
• Have had a liver biopsy that showed NASH or are willing to undergo a biopsy
• Have or ever had type 2 diabetes or 2 out of 4 signs of metabolic syndrome (overweight, have high cholesterol, blood pressure, and/or blood glucose)
• Have a body mass index (BMI) ≥25.0 kg/m².

PBC CymaBay CB8025-32251: "IDEAL" A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3
study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in
Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to
Ursodeoxycholic Acid (UDCA)

The purpose of this clinical research study is to determine if seladelpar, an investigational drug, is effective at normalizing disease markers in subjects with PBC who are currently on UDCA (URSO) treatment or are intolerant to UDCA (URSO).  Additionally, the study will test seladelpar's ability to relieve itching in PBC patients who qualify for the study and experience moderate to severe itch.

You may qualify for the study if:

• You are 18 - 75 years of age
• You have a confirmed diagnosis of PBC
• You have taken UDCA (URSO) for the 12 months prior to screening OR have had an incomplete or intolerant response 3 months prior to screening.

CymaBay CB8025-41837: "AFFIRM" A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Doctors usually prescribe UDCA (URSO) to help manage PBC, but it works better for some people than for others. This study will assess the effect of seladelpar on clinical outcomes, whether or not you are currently on UDCA (URSO).

You may qualify for this study if:

• You are 18 - 75 years of age
• You have been diagnosed with PBC
• You have a diagnosis of compensated cirrhosis with a Child-Pugh Score of A or B.

Merck MK7240-001: "Atlas-UC" -  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis 

More than 5 million people worldwide have ulcerative colitis (UC). It can cause pain, stomach cramps, bloody diarrhea, and rectal bleeding. There are treatments for UC, but no cure. Researchers are testing an investigational medicine in people diagnosed with moderately to severely active UC. They are evaluating the safety of the investigational medicine and how well it may work compared to a placebo.
You may qualify to take part in this study if you are 16-75 years old and:
• You have had UC for at least 3 months and currently have moderately to severely active UC
• You have had at least 1 of the below:
• Have not responded well or stopped responding to at least 1 UC treatment
• Have not tolerated your dose of corticosteroids being reduced (such as prednisone, budesonide, or beclomethasone)
• Have not been able to tolerate taking at least 1 UC treatment.