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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525755-82 | Registry Identifier | EU CT Number |
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This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving efimosfermin alfa | Experimental |
| |
| Participants receiving placebo | Placebo Comparator |
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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 |
|---|---|---|
| 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. | From Randomization (Day 1) to Week 356 (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 terminated asset(s) 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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This is a double-blind study.
| Placebo | Drug | Placebo (subcutaneous injection) will be administered. |
|
| Baseline (Day 1), Week 96, and Week 260 |
| 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. | Baseline (Day 1), Week 96, and Week 260 |
| Proportion of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity | Week 96, Week 260 and Week 356 (end of treatment) |
| Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity | Week 96, Week 260 and Week 356 (end of treatment) |
| Proportion of participants with Grade 3 and Grade 4 laboratory abnormalities | Week 96, Week 260 and Week 356 (end of treatment) |
| Absolute change from Baseline in VCTE-LSM | Baseline (Day 1), Week 96, Week 260, and Week 356 (end of treatment) |
| Relative change from Baseline in VCTE-LSM | Baseline (Day 1), Week 96, Week 260, and Week 356 (end of treatment) |
| Absolute change from Baseline in Magnetic resonance elastography (MRE) scores | MRE is a non-invasive imaging technique that combines magnetic resonance imaging (MRI) scanning with low-frequency mechanical vibrations to measure the stiffness of liver. MRE scores less than (<) 2.5 is normal, 2.5 - 3.0 Normal or inflammation, 3.0 - 3.5 Stage 1-2 fibrosis, 3.5 - 4.0 Stage 2-3 fibrosis, 4.0 - 5.0 Stage 3-4 fibrosis and greater than (>) 5.0 Stage 4 fibrosis. | Baseline (Day 1), Week 96, and Week 260 |
| Relative change from Baseline in MRE scores | MRE is a non-invasive imaging technique that combines magnetic resonance imaging (MRI) scanning with low-frequency mechanical vibrations to measure the stiffness of liver. MRE scores <2.5 is normal, 2.5 - 3.0 Normal or inflammation, 3.0 - 3.5 Stage 1-2 fibrosis, 3.5 - 4.0 Stage 2-3 fibrosis, 4.0 - 5.0 Stage 3-4 fibrosis and > 5.0 Stage 4 fibrosis | Baseline (Day 1), Week 96, and Week 260 |
| Absolute change from Baseline in ELF scores | The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score <9.8: Low risk of progression, ELF score 9.8 to <11.3: Moderate risk of progression and ELF score greater than or equal to (>=) 11.3: High risk of progression. | Baseline (Day 1), Week 96, Week 260, and Week 356 (end of treatment) |
| Relative change from Baseline in ELF scores | The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score <9.8: Low risk of progression, ELF score 9.8 to <11.3: Moderate risk of progression and ELF score >=11.3: High risk of progression. | Baseline (Day 1), Week 96, Week 260, and Week 356 (end of treatment) |
| Proportion of participants experiencing improvement in ELF score | The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score <9.8: Low risk of progression, ELF score 9.8 to <11.3: Moderate risk of progression and ELF score >=11.3: High risk of progression. | Week 96, Week 260 and Week 356 (end of treatment) |
| Change from Baseline in glycated hemoglobin (HbA1c) (Percentage of HbA1c) in participants with Type 2 Diabetes Mellitus (T2DM) | Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment) |
| Change from Baseline in fasting glucose (Millimole per Liter) in participants with T2DM | Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment) |
| Change from Baseline in fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)- cholesterol, and fasting triglycerides (Millimoles per liter) | Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment) |
| Change from Baseline in Patient-reported outcomes measurement information system (PROMIS)-Fatigue score | PROMIS-Fatigue is designed to assess fatigue-related symptoms (i.e., tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (i.e., activity limitations related to work, self-care, and exercise) over 7 items with a recall period of the previous 7 days. The items will be scored on a 5-point verbal rating scale (VRS) ranging from 1 (never) to 5 (always). Item scores are summed to generate a raw total score that ranges from 7 to 35, with higher scores indicates greater fatigue. | Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment) |
| Change from Baseline in Chronic Liver Disease Questionnaire-Nonalcoholic Steatohepatitis (CLDQ-NASH) domain and total score | CLDQ-NASH is a NASH-specific health-related quality of life (HRQoL) Patient-Reported Outcomes (PRO) designed to assess 6 health domains over 36 items: abdominal symptoms (3 items), activity/energy (5 items), emotional health (9 items), fatigue (6 items), systemic symptoms (6 items) and worry (7 items). The domain scores range from 1 to 7, higher scores indicating better HRQoL. A score of 1 meaning the symptom being assessed is "present always" while a score of 7 means the symptom is "never present". The total score can range from 36 to 252, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. | Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment) |
| Change from Baseline in Short Form-36 (SF-36) component and domain scores | SF-36 is a generic HRQoL PRO designed to assess 8 health domains over 36 items: physical functioning (10 items), bodily pain (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), general health (5 items), mental health (5 items), social functioning (2 items), and vitality (4 items). Each domain is scored from 0 (poorer health) to 100 (better health). SF-36 is scored into 8 domains and 2 component scores: physical component summary (PCS) and mental component summary (MCS). The domain and component scores range from 0 to 100, with higher scores indicating better HRQoL. | Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment) |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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