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A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

ConditionMetabolic Dysfunction-associated Steatohepatitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGlaxoSmithKline

About this trial

This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants aged between 18 and 75 years at enrolment.

Participants with history or presence of at least two components of metabolic syndrome.

Liver biopsy consistent with cirrhosis (fibrosis stage 4).

Disqualifiers

Participants with other chronic liver diseases.

Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.

Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications.

History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Efimosfermin alfa

    Drug

    Efimosfermin alfa (subcutaneous injection) will be administered.

  • Placebo

    Drug

    Placebo (subcutaneous injection) will be administered.

Treatment groups

380 Participants
are divided into 3 treatment groups
Group A: Part A: Participants receiving Efimosfermin alfaExperimental treatment 1 intervention
Group B: Part A: Participants receiving PlaceboPlacebo comparator 1 intervention
Group C: Part B: Participants receiving Efimosfermin alfaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH

Participants experiencing improvement in liver fibrosis of \>=1 stage (based on MASH Clinical Research Network (CRN) fibrosis score) and no worsening of MASH (defined as no increase in nonalcoholic fatty liver disease activity score for ballooning, inflammation, or steatosis). MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.

Time frame
At Week 96

Secondary outcomes

1

Part A: Proportion of participants achieving change from Baseline in vibration-controlled transient elastography (VCTE)- liver stiffness measurement (LSM) and in enhanced liver fibrosis (ELF) score

VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascal (kPa). ELF score (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis) is a blood-based noninvasive test used as a prognostic marker for disease progression.

Time frame
Baseline (Day 1) and Week 96
2

Part A Change from Baseline in VCTE-LSM

VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kPa.

Time frame
Baseline (Day 1) and Week 96
3

Part A: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) and TEAEs by severity

Time frame
Week 96
4

Part A: Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity

Time frame
Week 96

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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