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NCT07791043
A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
Conditions: Liver Diseases, Alcoholic
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 274
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site Topeka Kansas
Summary
This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.
Eligibility Criteria
Inclusion Criteria:
* Participant must be 18 to 75 years of age inclusive, at the time of Screening.
* Capable of giving signed informed consent prior to the performance of any study-specific procedures.
* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
* History of heavy alcohol consumption for greater than 6 months at any time prior to Screening.
* A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
* Is a Participant of non-childbearing potential (PONCBP) OR
* Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\
Source: ClinicalTrials.gov (NCT07791043). StuddyBuddy aggregates publicly available trial information.