Non-alcoholic Fatty Liver DiseasePhase 1NCT07335198
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry
A Phase 1 study testing Efimosfermin alfa in people with Non-alcoholic Fatty Liver Disease, run by GlaxoSmithKline at 1 site in New Zealand.
Trial summary
This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Efimosfermin alfa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNew Zealand
- Study dates
- 5 Mar 2026to 13 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are generally healthy as determined by medical evaluation
- Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants
- Body mass index (BMI) within the range of 18.0 to 28.0 kilograms per square meter (kg/m^2) (inclusive)
- Male and female participants
- Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong, or Taiwan, and descendant of 2 ethnic Chinese parents and 4 ethnic Chinese grandparents; and have lived outside China, Hong Kong, or Taiwan for less than 10 years at the time of screening.
- Participants of Japanese ancestry are eligible if born in Japan and descendant of 2 ethnic Japanese parents and 4 ethnic Japanese grandparents; and have lived outside Japan for less than 10 years at the time of screening.
- Participants of White/European ancestry are eligible if self-identified as being of White/European ancestry, (that is [i.e.], from the original peoples of Europe) irrespective of current place of residence; and descendant of 2 parents and 4 grandparents of White/European ancestry (i.e., from the original peoples of Europe) irrespective of place of birth or current place of residence.
Who cannot join
- History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Current or chronic history of liver or biliary disease with the exception of Gilbert's syndrome or asymptomatic gallstones.
- History of pancreatic injury, pancreatitis or other pancreatic disease; history of Type one Diabetes Mellitus (T1DM) or positive glutamic acid decarboxylase auto-antibodies, or major Type two Diabetes Mellitus (T2DM) complications including severe gastroparesis and autonomic neuropathy.
- Abnormal blood pressure (defined as systolic Blood Pressure [BP] more than equal [>=]140 millimeters of mercury [mmHg] or diastolic BP >=90 mmHg measured based on the average of triplicate BP readings).
- History of metabolic bone disorders including osteoporosis, osteopenia, or osteomalacia.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
Show all 19Show fewer
- Alanine transaminase (ALT) more than (>)1.5 * upper limit of normal (ULN).
- Total bilirubin >1.5 * ULN
- Known bleeding disorder.
- History of immunodeficiency diseases, including a positive test result for human immunodeficiency virus (HIV).
- Corrected QT Interval using Fridericia's Formula (QTcF) >=450 millisecond (msec)(male) or >=470 msec (female) at Screening Visit based on the average of triplicate ECGs.
- Use of statins, other lipid lowering medications or hypertension medications unless on a stable dose for at least 3 months.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever was longer; or longer if required by local regulations.
- Participants who have received native FGF21 or a FGF21 analog at any time in the past.
- Intended use of over the counter (OTC) or prescription medication (including herbal medications) within 7 days prior to dosing and for the duration of study participation.
- Live vaccine within 14 days prior to dosing and non-live vaccines for 7 days prior study dosing.
- Current enrolment or participation in another clinical trial within the last 30 days before signing consent of current study.
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody at screening or within 3 months prior to the first dose of study intervention
- A positive pre-study drug/alcohol screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry
This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Efimosfermin alfa, Placebo
- Keywords
- Efimosfermin alfa, Placebo, First time in Asia, Chinese, Japanese, White/Europeans, Pharmacokinetics, Safety, Immunogenicity
- 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 administered
PlaceboDrug
Placebo to be administered
| Study group | Role | What they receive |
|---|---|---|
| Efimosfermin alfa in participants of Chinese Ancestry | Experimental | Healthy participants of Chinese ancestry will be randomized to receive efimosfermin alfa. Receives: Drug: Efimosfermin alfa |
| Efimosfermin alfa in participants of Japanese Ancestry | Experimental | Healthy participants of Japanese ancestry will be randomized to receive efimosfermin alfa. Receives: Drug: Efimosfermin alfa |
| Efimosfermin alfa in participants of White/European Ancestry | Experimental | Healthy participants of White/European ancestry will be randomized to receive efimosfermin alfa. Receives: Drug: Efimosfermin alfa |
| Placebo in participants of Chinese Ancestry | Placebo comparator | Healthy participants of Chinese ancestry will be randomized to receive Placebo. Receives: Drug: Placebo |
| Placebo in participants of Japanese Ancestry | Placebo comparator | Healthy participants of Japanese ancestry will be randomized to receive Placebo. Receives: Drug: Placebo |
| Placebo in participants of White/European Ancestry | Placebo comparator | Healthy participants of White/European ancestry will be randomized to receive Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 12 Lead electrocardiogram (ECG)
Measured: Up to 90 days
Number of participants with clinically significant changes in vital signs
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
Area under the serum drug concentration versus time curve from time zero extrapolated to infinity (AUC[0-inf]) of efimosfermin alfa
Measured: Up to 90 days
Maximum observed serum drug concentration, determined directly from the serum concentration-time data (Cmax) of efimosfermin alfa
Measured: Up to 90 days
Secondary outcomes (8)
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
Area under the serum drug concentration versus time curve from time zero to 45 days [AUC(0-45days)] of efimosfermin alfa
Measured: Up to 45 days
Area under the serum drug concentration versus time curve from time zero to 60 days [AUC(0-60days)] of efimosfermin alfa
Measured: Up to 60 days
Area under the serum drug concentration versus time curve from time zero to 90 days [AUC(0-90days)] of efimosfermin alfa
Measured: Up to 90 days
Time of last quantifiable plasma drug concentration (Tlast) of efimosfermin alfa
Measured: Up to 90 days
Apparent clearance (CL/F) of efimosfermin alfa
Measured: Up to 90 days
Apparent volume of distribution (Vz/F) 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 posted13 Jan 2026
- Study start5 Mar 2026
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
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
- NCT07335198
- Sponsor's protocol ID
- 301158
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry
- ClinicalTrials.gov ID
- NCT07335198
- Acronym / sponsor ID
- 301158
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Efimosfermin alfa, Placebo, First time in Asia, Chinese, Japanese, White/Europeans, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 13 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 is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Efimosfermin alfa in participants of Chinese Ancestry | Experimental | Drug: Efimosfermin alfaHealthy participants of Chinese ancestry will be randomized to receive efimosfermin alfa. |
| Efimosfermin alfa in participants of Japanese Ancestry | Experimental | Drug: Efimosfermin alfaHealthy participants of Japanese ancestry will be randomized to receive efimosfermin alfa. |
| Efimosfermin alfa in participants of White/European Ancestry | Experimental | Drug: Efimosfermin alfaHealthy participants of White/European ancestry will be randomized to receive efimosfermin alfa. |
| Placebo in participants of Chinese Ancestry | Placebo comparator | Drug: PlaceboHealthy participants of Chinese ancestry will be randomized to receive Placebo. |
| Placebo in participants of Japanese Ancestry | Placebo comparator | Drug: PlaceboHealthy participants of Japanese ancestry will be randomized to receive Placebo. |
| Placebo in participants of White/European Ancestry | Placebo comparator | Drug: PlaceboHealthy participants of White/European ancestry will be randomized to receive Placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants who are generally healthy as determined by medical evaluation
- Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants
- Body mass index (BMI) within the range of 18.0 to 28.0 kilograms per square meter (kg/m^2) (inclusive)
- Male and female participants
- Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong, or Taiwan, and descendant of 2 ethnic Chinese parents and 4 ethnic Chinese grandparents; and have lived outside China, Hong Kong, or Taiwan for less than 10 years at the time of screening.
Key exclusion criteria (19 listed)
- History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Current or chronic history of liver or biliary disease with the exception of Gilbert's syndrome or asymptomatic gallstones.
- History of pancreatic injury, pancreatitis or other pancreatic disease; history of Type one Diabetes Mellitus (T1DM) or positive glutamic acid decarboxylase auto-antibodies, or major Type two Diabetes Mellitus (T2DM) complications including severe gastroparesis and autonomic neuropathy.
- Abnormal blood pressure (defined as systolic Blood Pressure [BP] more than equal [>=]140 millimeters of mercury [mmHg] or diastolic BP >=90 mmHg measured based on the average of triplicate BP readings).
- History of metabolic bone disorders including osteoporosis, osteopenia, or osteomalacia.
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 administered | Drug | Efimosfermin alfa in participants of Chinese Ancestry, Efimosfermin alfa in participants of Japanese Ancestry, Efimosfermin alfa in participants of White/European Ancestry |
| PlaceboPlacebo to be administered | Drug | Placebo in participants of Chinese Ancestry, Placebo in participants of Japanese Ancestry, Placebo in participants of White/European Ancestry |
Primary outcome
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 12 Lead electrocardiogram (ECG)
Time frame: Up to 90 days
Number of participants with clinically significant changes in vital signs
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
Area under the serum drug concentration versus time curve from time zero extrapolated to infinity (AUC[0-inf]) of efimosfermin alfa
Time frame: Up to 90 days
Maximum observed serum drug concentration, determined directly from the serum concentration-time data (Cmax) of efimosfermin alfa
Time frame: Up to 90 days
8 secondary outcomes
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
Area under the serum drug concentration versus time curve from time zero to 45 days [AUC(0-45days)] of efimosfermin alfa
Time frame: Up to 45 days
Area under the serum drug concentration versus time curve from time zero to 60 days [AUC(0-60days)] of efimosfermin alfa
Time frame: Up to 60 days
Area under the serum drug concentration versus time curve from time zero to 90 days [AUC(0-90days)] of efimosfermin alfa
Time frame: Up to 90 days
Time of last quantifiable plasma drug concentration (Tlast) of efimosfermin alfa
Time frame: Up to 90 days
Apparent clearance (CL/F) of efimosfermin alfa
Time frame: Up to 90 days
Apparent volume of distribution (Vz/F) of efimosfermin alfa
Time frame: Up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site 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 1 site in New Zealand.
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 19 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: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs) (time frame: Up to 90 days). The study lists 7 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 21 Sep 2026.