Last updated: 07/07/2026 07:20:57
A study of efimosfermin alfa in participants with biopsy-confirmed cirrhosis (compensated) due to MASH
GSK study ID
306301
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Phase 2, randomized, double-blinded, placebo-controlled study of efimosfermin alfa in participants with biopsy-confirmed cirrhosis (compensated) due to metabolic dysfunction-associated steatohepatitis (MASH)
Trial description: The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with treatment emergent adverse events (TEAEs)
Timeframe: From Day 1 to 100 weeks
Secondary outcomes:
Serum concentrations of efimosfermin
Timeframe: Up to Week 21
Maximum serum drug concentration (Cmax) of efimosfermin
Timeframe: Up to Week 21
Area under the serum concentration-time curve (AUC) of efimosfermin
Timeframe: Up to Week 21
Average serum drug concentration (Cavg) of efimosfermin
Timeframe: Up to Week 21
Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin
Timeframe: Up to Week 21
Interventions:
Drug: Efimosfermin
Drug: Placebo
Enrollment:
42
Observational study model:
Not applicable
Primary completion date:
2028-10-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2025 to July 2028
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
- Ability to understand and sign a written informed consent form (ICF)
- Age 18 through 75 years at enrollment
- Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
- History of type 1 diabetes
Inclusion and exclusion criteria
Inclusion criteria:
- Age 18 through 75 years at enrollment
- History or presence of 2 or more of the 5 components of metabolic syndrome
- Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
- Other inclusion criteria may apply.
Ability to understand and sign a written informed consent form (ICF)
Exclusion criteria:
- History of type 1 diabetes
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
- Other exclusion criteria may apply.
Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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