Metabolic Dysfunction-associated SteatohepatitisPhase 3NEBULA-1NCT07701993
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)
A Phase 3 study testing Efimosfermin alfa in people with Metabolic Dysfunction-associated Steatohepatitis, run by GlaxoSmithKline at 30 sites in 2 countries.
Trial summary
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-associated Steatohepatitis
- What is being tested?
- Efimosfermin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,740 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 22 Jul 2026to 24 Aug 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.
- Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=5 times upper limit normal (ULN).
- Participants with current or history of excessive alcohol intake.
Trial locations and contacts
30 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 2 countries
United States28 sites, 28 recruiting
- Recruiting
GSK Investigational Site
Arlington, Texas, 76012
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Austin, Texas, 78745-5675
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Austin, Texas, 78759
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Bellaire, Texas, 77401
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Cape Coral, Florida, 33914
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Dallas, Texas, 75243-1921
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Folsom, California, 95630
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fort Myers, Florida, 33912
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Hialeah, Florida, 33016
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Homestead, Florida, 33033
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Humble, Texas, 77346
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kissimmee, Florida, 34744-4574
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Lakeland, Florida, 33803
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Little Rock, Arkansas, 72211
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Manassas, Virginia, 20110
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33135-4661
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33155
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Morehead City, North Carolina, 28557
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
New York, New York, 10036-4103
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ocala, Florida, 34471
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Antonio, Texas, 78209
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Antonio, Texas, 78215
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Santa Maria, California, 93458
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
St Louis, Missouri, 63141
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
University Park, Florida, 34201
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Waco, Texas, 76710
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
West Jordan, Utah, 84088
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Westlake, Ohio, 44145-1493
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Japan2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Kawasaki-shi, 215-0026
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ōgaki, Gifu, 503-8502
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
- Being tested
- Efimosfermin alfa, Placebo
- Keywords
- Efimosfermin alfa, Metabolic dysfunction-associated, steatohepatitis, Fibrosis, Cirrhosis
- Medical subject headings
- Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efimosfermin alfaDrug
Efimosfermin alfa (subcutaneous injection) will be administered.
PlaceboDrug
Placebo (subcutaneous injection) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving efimosfermin alfa | Experimental | Not described Receives: Drug: Efimosfermin alfa |
| Participants receiving placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Randomization (Day 1) to Week 356 (end of treatment)
Secondary outcomes (18)
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.
Measured: 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.
Measured: Baseline (Day 1), Week 96, and Week 260
Proportion of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Measured: 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
Measured: Week 96, Week 260 and Week 356 (end of treatment)
Proportion of participants with Grade 3 and Grade 4 laboratory abnormalities
Measured: Week 96, Week 260 and Week 356 (end of treatment)
Absolute change from Baseline in VCTE-LSM
Measured: Baseline (Day 1), Week 96, Week 260, and Week 356 (end of treatment)
Relative change from Baseline in VCTE-LSM
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start22 Jul 2026
- Primary completion23 Jun 2033 (estimated)
- Study completion24 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated SteatohepatitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701993
- Sponsor's protocol ID
- 306300
- Other IDs
- 2026-525755-82, 2026-525755-82
- Acronym
- NEBULA-1
- Status last verified
- Nov 2026
- First submitted
- 9 Jul 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)
- ClinicalTrials.gov ID
- NCT07701993
- Acronym / sponsor ID
- NEBULA-1 / 306300
- Keywords
- Efimosfermin alfa, Metabolic dysfunction-associated, steatohepatitis, Fibrosis, Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,740 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 23 Jun 2033 (estimated)
- Study completion
- 24 Aug 2033 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving efimosfermin alfa | Experimental | Drug: Efimosfermin alfa |
| Participants receiving placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efimosfermin alfaEfimosfermin alfa (subcutaneous injection) will be administered. | Drug | Participants receiving efimosfermin alfa |
| PlaceboPlacebo (subcutaneous injection) will be administered. | Drug | Participants receiving placebo |
Primary outcome
Time from randomization to an adjudicated composite liver-related clinical outcome
Time frame: From Randomization (Day 1) to Week 356 (end of treatment)
Liver-related outcome comprises all-cause mortality; liver transplantation; occurrence of significant hepatic decompensation events.
18 secondary outcomes
Proportion of participants achieving change from Baseline in vibration-controlled transient elastography- liver stiffness measurement (VCTE-LSM) and in enhanced liver fibrosis (ELF) score
Time frame: Baseline (Day 1), Week 96, and Week 260
Proportion of participants achieving change from Baseline in VCTE-LSM
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
Time frame: Baseline (Day 1), Week 96, and Week 260
Relative change from Baseline in MRE scores
Time frame: Baseline (Day 1), Week 96, and Week 260
Absolute change from Baseline in ELF scores
Time frame: Baseline (Day 1), Week 96, Week 260, and Week 356 (end of treatment)
Relative change from Baseline in ELF scores
Time frame: Baseline (Day 1), Week 96, Week 260, and Week 356 (end of treatment)
Proportion of participants experiencing improvement in ELF score
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
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
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
Time frame: Baseline (Day 1), Week 96, Week 260 and Week 356 (end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efimosfermin alfa in people with Metabolic Dysfunction-associated Steatohepatitis, run by GlaxoSmithKline at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomization to an adjudicated composite liver-related clinical outcome (time frame: From Randomization (Day 1) to Week 356 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.