A Phase 3 interventional study of Efimosfermin alfa and Placebo in Metabolic Dysfunction-associated Steatohepatitis, sponsored by GlaxoSmithKline. Recruiting at 30 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.
This study's planned enrollment of 1,740 is above the median of 60 across 431 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Efimosfermin alfa
Drug: Placebo
Efimosfermin alfa (subcutaneous injection) will be administered.
Placebo (subcutaneous injection) will be administered.
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)
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
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
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)
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)
Proportion of participants with Grade 3 and Grade 4 laboratory abnormalities
Time frame: Week 96, Week 260 and Week 356 (end of treatment)
Absolute change from Baseline in VCTE-LSM
Time frame: Baseline (Day 1), Week 96, Week 260, and Week 356 (end of treatment)
Relative change from Baseline in VCTE-LSM
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment)
Plan to share: Yes — 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · www.gsk-studyregister.com
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jun 2033, 83 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Efimosfermin alfa