Non-alcoholic Fatty Liver DiseasePhase 1NCT07358546
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
A Phase 1 study testing Efimosfermin alfa in people with Non-alcoholic Fatty Liver Disease, run by GlaxoSmithKline at 5 sites in United States.
Trial summary
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Efimosfermin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Mar 2026to 13 Oct 2027
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 years and 70 years of age inclusive
- Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg/m^2)
- Male or female participants
- Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:
- Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or compatible biochemical profile, and
- Be classed during Screening as one of the following Child-Pugh classes:
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- Child-Pugh B: Score 7-9 or
- Child-Pugh C: Score 10-15
- Chronic (greater than [>] 6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also remain stable throughout the Screening period. Assessment of the stability of the participant's hepatic function will be determined by the investigator.
Who cannot join
- History of extrahepatic disorders possibly related to etiology of cirrhosis.
- History of cryoglobulinemia.
- Participants with Grade 3 ascites or refractory ascites.
- Participants with refractory encephalopathy or significant central nervous system disease
- History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures.
- Other primary causes of liver disease. Steatotic liver disease must be the primary cause of liver disease.
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- Clinically significant abnormalities affecting physical health in medical history, or on physical examination, that could interfere with or for which treatment could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study.
- Current, or history of known hepatocellular carcinoma (HCC).
- Participants with transjugular intrahepatic portosystemic shunt (TIPS) placement.
- Presence of hepatopulmonary or hepatorenal syndrome.
- Presence of primarily cholestatic liver diseases.
- Evidence of symptomatic or complicated cholecystitis.
- History of pancreatic injury, pancreatitis, or other pancreatic disease.
- History of liver transplantation, or active on the liver transplant waiting list.
- Participants with signs of active infection
- History of adrenal gland disease or using treatment that affects the hypothalamic-pituitary-adrenal axis.
- History of significant bone disease such as osteoporosis
- Psychosocial features that, in the opinion of the investigator, increase the likelihood of loss to follow-up.
- History or presence of drug abuse.
- Use of other investigational drugs at the time of screening, or within 5 half-lives or 30 days prior to study intervention, whichever was longer; or longer if required by local regulations
- Have previously taken efimosfermin alfa
- Participants with Alanine Aminotransferase (ALT) value >3 times (x) upper limit of normal (ULN)
- Participants with Aspartate aminotransferase (AST) value >=300 Units/Liter.
- Participants with estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology [CKD-Epi] 2021) <45 milliliter/minute/1.73 square meter (mL/min/1.73m^2).
- Average of triplicate QT interval corrected for heart rate using Fridericia formula (QTcF) >480 milliseconds (msec) (for male and female participants) at Screening
- For participants in the MASH with alcohol category, significant risk of withdrawal symptoms.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Houston, Texas, 77079
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
Rialto, California, 92377
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
Tampa, Florida, 33603
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 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Efimosfermin alfa
- Keywords
- efimosfermin alfa, Alcohol, Hepatic Impairment, Steatotic liver disease, Metabolic Dysfunction-Associated Steatohepatitis, Pharmacokinetics
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efimosfermin alfaDrug
Efimosfermin alfa to be administrated subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol | Experimental | All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) with typical alcohol consumption threshold in the 3 months prior to Screening of less than (<) 5 standard drinks on any day and <15 standard drinks per week for men; or <4 standard drinks on any day and <8 standard drinks per week for women. Receives: Drug: Efimosfermin alfa |
| Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcohol | Experimental | All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to MASH with typical alcohol consumption threshold in the 3 months prior to Screening of greater than or equal to (>=) 5 standard drinks per day or >=15 standard drinks per week for men; or >= 4 standard drinks per day or >=8 or more drinks per week for women. Receives: Drug: Efimosfermin alfa |
| Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol use | Experimental | All participants will receive efimosfermin alfa. Participants will have severe hepatic impairment (Child-Pugh C) due to MASH with any typical daily alcohol consumption. Receives: Drug: Efimosfermin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa
Measured: Up to 90 Days
Maximum observed serum drug concentration (Cmax) of efimosfermin alfa
Measured: Up to 90 Days
Secondary outcomes (10)
Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)
Measured: Up to 90 Days
Number of participants with clinically significant changes in hematology, chemistry, and urinalysis parameters
Measured: Up to 90 Days
Number of participants with clinically significant changes in Vital signs and 12-lead electrocardiogram (ECG) findings
Measured: Up to 90 Days
Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa
Measured: Up to 90 Days
Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa
Measured: Up to 90 Days
Apparent terminal phase half-life (t1/2) of efimosfermin alfa
Measured: Up to 90 Days
Time prior to the first measurable (non-zero) serum concentration (Tlag) of efimosfermin alfa
Measured: Up to 90 Days
Apparent clearance (CL/F) of efimosfermin alfa
Measured: Up to 90 days
Apparent terminal phase volume of distribution (Vz/F) of efimosfermin alfa
Measured: Up to 90 days
Terminal elimination rate constant (Lambda z) of efimosfermin alfa
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start13 Mar 2026
- Primary completion13 Oct 2027 (estimated)
- Study completion13 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT07358546
- Sponsor's protocol ID
- 306836
- Status last verified
- Nov 2026
- First submitted
- 14 Jan 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07358546
- Acronym / sponsor ID
- 306836
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- efimosfermin alfa, Alcohol, Hepatic Impairment, Steatotic liver disease, Metabolic Dysfunction-Associated Steatohepatitis, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 13 Oct 2027 (estimated)
- Study completion
- 13 Oct 2027 (estimated)
- First posted
- 22 Jan 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 is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol | Experimental | Drug: Efimosfermin alfaAll participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) with typical alcohol consumption threshold in the 3 months prior to Screening of less than (<) 5 standard drinks on any day and <15 standard drinks per week for men; or <4 standard drinks on any day and <8 standard drinks per week for women. |
| Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcohol | Experimental | Drug: Efimosfermin alfaAll participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to MASH with typical alcohol consumption threshold in the 3 months prior to Screening of greater than or equal to (>=) 5 standard drinks per day or >=15 standard drinks per week for men; or >= 4 standard drinks per day or >=8 or more drinks per week for women. |
| Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol use | Experimental | Drug: Efimosfermin alfaAll participants will receive efimosfermin alfa. Participants will have severe hepatic impairment (Child-Pugh C) due to MASH with any typical daily alcohol consumption. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 18 years and 70 years of age inclusive
- Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg/m^2)
- Male or female participants
- Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:
- Chronic (greater than [>] 6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also remain stable throughout the Screening period. Assessment of the stability of the participant's hepatic function will be determined by the investigator.
Key exclusion criteria (26 listed)
- History of extrahepatic disorders possibly related to etiology of cirrhosis.
- History of cryoglobulinemia.
- Participants with Grade 3 ascites or refractory ascites.
- Participants with refractory encephalopathy or significant central nervous system disease
- History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures.
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 to be administrated subcutaneously | Drug | Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcohol, Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol, Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol use |
Primary outcome
Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa
Time frame: Up to 90 Days
Maximum observed serum drug concentration (Cmax) of efimosfermin alfa
Time frame: Up to 90 Days
10 secondary outcomes
Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)
Time frame: Up to 90 Days
Number of participants with clinically significant changes in hematology, chemistry, and urinalysis parameters
Time frame: Up to 90 Days
Number of participants with clinically significant changes in Vital signs and 12-lead electrocardiogram (ECG) findings
Time frame: Up to 90 Days
Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa
Time frame: Up to 90 Days
Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa
Time frame: Up to 90 Days
Apparent terminal phase half-life (t1/2) of efimosfermin alfa
Time frame: Up to 90 Days
Time prior to the first measurable (non-zero) serum concentration (Tlag) of efimosfermin alfa
Time frame: Up to 90 Days
Apparent clearance (CL/F) of efimosfermin alfa
Time frame: Up to 90 days
Apparent terminal phase volume of distribution (Vz/F) of efimosfermin alfa
Time frame: Up to 90 days
Terminal elimination rate constant (Lambda z) of efimosfermin alfa
Time frame: Up to 90 days
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Efimosfermin alfa in people with Non-alcoholic Fatty Liver Disease, run by GlaxoSmithKline at 5 sites in United States.
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 9 inclusion and 26 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 5 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa (time frame: Up to 90 Days). 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.