A Phase IIa double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 3802876 in participants with compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Date Added
April 28th, 2026
PRO Number
Pro00148327
Researcher
Don Rockey

List of Studies

Keywords
Liver
Summary

To investigate the safety, tolerability, PD, and PK of BI 3802876
when administered intravenously in single rising doses following
MABEL dose administration in adult patients with compensated
cirrhosis due to MASH.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768439
blanke@musc.edu

Case-Control Study of a Novel Test for the Early Detection of Hepatocellular Carcinoma in at-risk Patients with Cirrhosis

Date Added
May 1st, 2026
PRO Number
Pro00149583
Researcher
Don Rockey

List of Studies

Keywords
Cancer, Liver
Summary

This study will enroll patients that were either diagnosed with hepatocellular cancer (HCC) in the past 6 weeks or have been diagnosed with cirrhosis but do not have HCC. Patients will have a blood sample collected to test if a new blood-based biomarker is accurate in the early detectection of HCC.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
(843)-876-8439
blanke@musc.edu

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (ELASCOPE)

Date Added
July 23rd, 2026
PRO Number
Pro00150319
Researcher
Don Rockey

List of Studies

Keywords
Liver
Summary

To evaluate if daily oral administration of elafibranor 120 mg improves the time of event free survival compared to placebo in adults with Primary Sclerosing Cholangitis (PSC).

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-4303
inmanj@musc.edu

A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study Of Inebilizumab In Participants With Autoimmune Hepatitis (MERCURY)

Date Added
August 4th, 2026
PRO Number
Pro00148992
Researcher
Don Rockey

List of Studies

Keywords
Liver
Summary

The aim of this study is to assess the efficacy and safety of an investigational medication, Inebilizumab, in patients with autoimmune hepatitis (AIH) who inadequately respond to at least 9 months of standard-of-care (SOC) treatment, or who are intolerant to SOC within 6 months of screening.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

Date Added
September 15th, 2026
PRO Number
Pro00149305
Researcher
Don Rockey

List of Studies

Keywords
Liver
Summary

This study is investigating how efimosfermin, compared to a placebo, might improve liver fibrosis in patients with biopsy-proven stage F2- or F3 Metabolic Dysfunction-Associated Steatohepatitis (MASH), also known as "fatty liver disease".

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
(843) 876-4303
blanke@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

Date Added
September 18th, 2026
PRO Number
Pro00149306
Researcher
Don Rockey

List of Studies

Keywords
Liver
Summary

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
(843) 876-4303
blanke@musc.edu

Management of GLP-1 agonists prior to endoscopy

Date Added
November 5th, 2026
PRO Number
Pro00139495
Researcher
Don Rockey

List of Studies

Keywords
Weight Control
Summary

This study will examine how medications called GLP-1 receptor agonists should be managed before an upper endoscopy. Participants taking a weekly GLP-1 receptor agonist will be randomly assigned to continue their medication, stop it for 7 days before the procedure, or stop it for 14 days before the procedure. Before the endoscopy, an ultrasound will be used to assess the amount and type of contents remaining in the stomach. The study will compare the groups to determine how different medication hold times affect the amount of stomach contents present at the time of endoscopy. The results may help inform future recommendations for managing GLP-1 receptor agonists before endoscopic procedures.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu



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