Liver Diseases, AlcoholicPhase 2ALLSTARNCT07791043
A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
A Phase 2 study testing Efimosfermin alfa in people with Liver Diseases, Alcoholic, run by GlaxoSmithKline at 13 sites in 4 countries.
Trial summary
This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Diseases, Alcoholic
- What is being tested?
- Efimosfermin alfa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 31 Aug 2026to 14 Jan 2030
- Phase
- Phase 2
- 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
- Participant must be 18 to 75 years of age inclusive, at the time of Screening.
- Capable of giving signed informed consent prior to the performance of any study-specific procedures.
- Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
- History of heavy alcohol consumption for greater than 6 months at any time prior to Screening.
- A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
- Is a Participant of non-childbearing potential (PONCBP) OR
- Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percentage (%), 30 days prior to and during the study intervention period and for at least 16 weeks after the last dose of study intervention.
Who cannot join
- Other primary causes of liver disease (e.g., viral hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, alpha-1-antitryspin deficiency, etc.). Alcohol must be the primary cause of liver disease.
- Co-infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) as indicated from the central lab
- History of diabetes mellitus (DM), either:
- Type 1 DM
- Type 2 DM with unstable glycemic control or with major complications.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the 3 years prior to Screening 1, regardless of any evidence of local recurrence or metastasis.
Show all 20Show fewer
- Current, or history of known hepatocellular carcinoma (HCC).
- Any major surgery within 3 months prior to Screening 1 or planned during the study
- Any surgical or medical condition that might jeopardize the individual's safety or compliance with study procedures in the opinion of the investigator.
- All organ transplant recipients, except for history of corneal transplants, or current listing or active consideration for liver transplant during the Screening period.
- Poorly controlled hypertension.
- Evidence of Wernicke-Korsakoff syndrome or alcohol-related dementia.
- Prior use of a Fibroblast growth factor 21 (FGF21) analogue, including efimosfermin, within the 6 months prior to Screening 1.
- Individuals with a history of resmetirom use within 3 months prior to Day 1 are to be excluded.
- Concomitant use of investigational drugs for Metabolic dysfunction-associated steatohepatitis (MASH) or ALD.
- Current or planned participation in any clinical trial of investigational therapies or medical devices.
- Exceeding pre-defined laboratory parameters for Triglycerides, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), International normalised ratio (INR), Albumin, Urine albumin-creatinine ratio (uACR) or Glycosylated Hemoglobin (HbA1c).
- History of drug abuse within the 12 months prior to Day 1 or evidence of such abuse as indicated by laboratory assays conducted at Screening.
- History of hypersensitivity (such as anaphylaxis or hepatotoxicity) to study intervention and/or its excipients, drugs of similar biological class, FGF21 protein analogs, Fc-fusion proteins, or other protein-based therapeutics.
- Overt hepatic encephalopathy (West Haven grade >=2).
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
United States5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Chandler, Arizona, 85224
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 Worth, Texas, 76104
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 Lakes, 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
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
Topeka, Kansas, 66606
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
Argentina4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Buenos Aires, 1061
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
CABA, C1056ABI
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
Rosario, S2002
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 Miguel de Tucumán, T4000IHE
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
South Korea3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Pusan, 49241
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
Seoul, 05505
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
Seoul, 135-710
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
Canada1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Toronto, Ontario, M1S 4T7
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 Dose-finding, Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Treatment With Efimosfermin Alfa in Adult Participants With Alcohol-related Liver Disease (ALD)
This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.
- Conditions
- Liver Diseases, Alcoholic
- Being tested
- Efimosfermin alfa, Placebo
- Keywords
- Efimosfermin alfa, Alcohol-related liver disease, Liver stiffness measurement, Advanced chronic liver disease
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efimosfermin alfaDrug
Efimosfermin alfa will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Efimosfermin alfa Dose Level 1 | Experimental | Participants will receive efimosfermin alfa dose level 1. Receives: Drug: Efimosfermin alfa |
| Efimosfermin alfa Dose Level 2 | Experimental | Participants will receive efimosfermin alfa dose level 2. Receives: Drug: Efimosfermin alfa |
| Efimosfermin alfa Dose Level 3 | Experimental | Participants will receive efimosfermin alfa dose level 3. Receives: Drug: Efimosfermin alfa |
| Placebo | Placebo comparator | Participants will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)
VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascals (kPa)
Measured: Baseline (Day 1) and up to Week 60
Change from Baseline in model for end-stage liver disease (MELD) score
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
Measured: Baseline (Day 1) and up to Week 60
Secondary outcomes (11)
Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter)
This is a measurement of the AST enzyme in the blood.
Measured: Baseline (Day 1) and up to Week 60
Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease
Measured: Baseline (Day 1) and up to Week 52
Trough Concentration at steady state (Ctrough,ss) following administration of efimosfermin alfa
Measured: Up to Week 56
Area Under the concentration-time Curve from Time 0 (pre-dose) to the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa in the subset of participants with optional intensive pharmacokinetics (PK) sampling
Measured: Up to Week 4
Maximum observed drug concentration (Cmax) of efimosfermin alfa in the subset of participants with optional intensive PK sampling
Measured: Up to Week 4
Number of Participants with Anti-drug antibodies (ADA) against efimosfermin alfa
Measured: Up to Week 56
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Measured: Up to Week 60
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Measured: Up to Week 60
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
Measured: Up to Week 60
Number of participants with clinically significant changes in Vital signs
Measured: Up to Week 60
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) findings
Measured: Up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start31 Aug 2026
- Primary completion11 Aug 2028 (estimated)
- Study completion14 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Diseases, AlcoholicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 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
- NCT07791043
- Sponsor's protocol ID
- 306837
- Other IDs
- 2026-526391-23, 2026-526391-23
- Acronym
- ALLSTAR
- Status last verified
- Nov 2026
- First submitted
- 21 Aug 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 Dose-finding, Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Treatment With Efimosfermin Alfa in Adult Participants With Alcohol-related Liver Disease (ALD)
- ClinicalTrials.gov ID
- NCT07791043
- Acronym / sponsor ID
- ALLSTAR / 306837
- Conditions
- Liver Diseases, Alcoholic
- Keywords
- Efimosfermin alfa, Alcohol-related liver disease, Liver stiffness measurement, Advanced chronic liver disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 11 Aug 2028 (estimated)
- Study completion
- 14 Jan 2030 (estimated)
- First posted
- 27 Aug 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 is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Efimosfermin alfa Dose Level 1 | Experimental | Drug: Efimosfermin alfaParticipants will receive efimosfermin alfa dose level 1. |
| Efimosfermin alfa Dose Level 2 | Experimental | Drug: Efimosfermin alfaParticipants will receive efimosfermin alfa dose level 2. |
| Efimosfermin alfa Dose Level 3 | Experimental | Drug: Efimosfermin alfaParticipants will receive efimosfermin alfa dose level 3. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must be 18 to 75 years of age inclusive, at the time of Screening.
- Capable of giving signed informed consent prior to the performance of any study-specific procedures.
- Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
- History of heavy alcohol consumption for greater than 6 months at any time prior to Screening.
- A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
Key exclusion criteria (20 listed)
- Other primary causes of liver disease (e.g., viral hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, alpha-1-antitryspin deficiency, etc.). Alcohol must be the primary cause of liver disease.
- Co-infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) as indicated from the central lab
- History of diabetes mellitus (DM), either:
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the 3 years prior to Screening 1, regardless of any evidence of local recurrence or metastasis.
- Current, or history of known hepatocellular carcinoma (HCC).
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 will be administered. | Drug | Efimosfermin alfa Dose Level 1, Efimosfermin alfa Dose Level 2, Efimosfermin alfa Dose Level 3 |
| PlaceboPlacebo will be administered. | Drug | Placebo |
Primary outcome
Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)
Time frame: Baseline (Day 1) and up to Week 60
VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascals (kPa)
Change from Baseline in model for end-stage liver disease (MELD) score
Time frame: Baseline (Day 1) and up to Week 60
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
11 secondary outcomes
Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter)
Time frame: Baseline (Day 1) and up to Week 60
Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease
Time frame: Baseline (Day 1) and up to Week 52
Trough Concentration at steady state (Ctrough,ss) following administration of efimosfermin alfa
Time frame: Up to Week 56
Area Under the concentration-time Curve from Time 0 (pre-dose) to the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa in the subset of participants with optional intensive pharmacokinetics (PK) sampling
Time frame: Up to Week 4
Maximum observed drug concentration (Cmax) of efimosfermin alfa in the subset of participants with optional intensive PK sampling
Time frame: Up to Week 4
Number of Participants with Anti-drug antibodies (ADA) against efimosfermin alfa
Time frame: Up to Week 56
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Time frame: Up to Week 60
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Time frame: Up to Week 60
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
Time frame: Up to Week 60
Number of participants with clinically significant changes in Vital signs
Time frame: Up to Week 60
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) findings
Time frame: Up to Week 60
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
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efimosfermin alfa in people with Liver Diseases, Alcoholic, run by GlaxoSmithKline at 13 sites in 4 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 7 inclusion and 20 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 13 sites in United States, Argentina, South Korea, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM) (time frame: Baseline (Day 1) and up to Week 60). The study lists 2 primary outcomes in all. 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; AzTrials last refreshed its copy on 8 Nov 2026.