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A Pivotal Clinical Study to Investigate the 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 study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants aged between 18 and 75 years at enrollment.

Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.

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

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 complications.

Participants with 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

1,740 Participants
are divided into 2 treatment groups
Group A: Participants receiving efimosfermin alfaExperimental treatment 1 intervention
Group B: Participants receiving placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from randomization to an adjudicated composite liver-related clinical outcome

Liver-related outcome comprises all-cause mortality; liver transplantation; occurrence of significant hepatic decompensation events.

Time frame
From Randomization (Day 1) to Week 356 (end of treatment)

Secondary outcomes

1

Proportion of participants achieving change from Baseline in vibration-controlled transient elastography- liver stiffness measurement (VCTE-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), Week 96, and Week 260
2

Proportion of participants achieving 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), Week 96, and Week 260
3

Proportion of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity

Time frame
Week 96, Week 260 and Week 356 (end of treatment)
4

Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity

Time frame
Week 96, Week 260 and Week 356 (end of treatment)

Other outcomes

Sponsors and contacts

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GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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