Non-alcoholic Fatty Liver Disease
Conditions
Keywords
Efimosfermin alfa, Placebo, First time in Asia, Chinese, Japanese, White/Europeans, Pharmacokinetics, Safety, Immunogenicity
Brief 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.
Interventions
Efimosfermin alfa to be administered
DRUGPlacebo
Placebo to be administered
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This is a double blinded study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs) | Up to 90 days |
| Number of participants with clinically significant changes in hematology, chemistry and urinalysis parameters | Up to 90 days |
| Number of participants with clinically significant changes in 12 Lead electrocardiogram (ECG) | Up to 90 days |
| Number of participants with clinically significant changes in vital signs | 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 | 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 | Up to 90 days |
| Maximum observed serum drug concentration, determined directly from the serum concentration-time data (Cmax) of efimosfermin alfa | Up to 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa | Up to 90 days |
| Apparent terminal phase half-life (t1/2) of efimosfermin alfa | 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 | 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 | 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 | Up to 90 days |
| Time of last quantifiable plasma drug concentration (Tlast) of efimosfermin alfa | Up to 90 days |
| Apparent clearance (CL/F) of efimosfermin alfa | Up to 90 days |
| Apparent volume of distribution (Vz/F) of efimosfermin alfa | Up to 90 days |
Countries
New Zealand
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed