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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525757-37 | Registry Identifier | EU CT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Participants receiving Efimosfermin alfa | Experimental | Participants will receive efimosfermin alfa in Part A of the study. |
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| Part A: Participants receiving Placebo | Placebo Comparator | Participants will receive placebo in Part A of the study. |
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| Part B: Participants receiving Efimosfermin alfa | Experimental | All participants will receive efimosfermin alfa in Part B of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efimosfermin alfa | Drug | Efimosfermin alfa (subcutaneous injection) will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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The Part A of study is a double-blind study
| Placebo | Drug | Placebo (subcutaneous injection) will be administered. |
|
| Baseline (Day 1) and Week 96 |
| 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. | Baseline (Day 1) and Week 96 |
| Part A: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) and TEAEs by severity | Week 96 |
| Part A: Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity | Week 96 |
| Part A: Proportion of participants with Grade 3 and Grade 4 laboratory abnormalities | Week 96 |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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