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

NCT07335198 | Active Not Recruiting Phase 1

• 1 other identifier: 301158
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Efimosfermin alfa; Placebo; First time in Asia; Chinese; Japanese; White/Europeans; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• 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 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

Study Arms (6)

Efimosfermin alfa in participants of Chinese Ancestry

EXPERIMENTAL

Healthy participants of Chinese ancestry will be randomized to receive efimosfermin alfa.

Drug: Efimosfermin alfa

Efimosfermin alfa in participants of Japanese Ancestry

EXPERIMENTAL

Healthy participants of Japanese ancestry will be randomized to receive efimosfermin alfa.

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

Drug: Efimosfermin alfa

Placebo in participants of Chinese Ancestry

PLACEBO COMPARATOR

Healthy participants of Chinese ancestry will be randomized to receive Placebo.

Drug: Placebo

Placebo in participants of Japanese Ancestry

PLACEBO COMPARATOR

Healthy participants of Japanese ancestry will be randomized to receive Placebo.

Drug: Placebo

Placebo in participants of White/European Ancestry

PLACEBO COMPARATOR

Healthy participants of White/European ancestry will be randomized to receive Placebo.

Drug: Placebo

Interventions

Efimosfermin alfa DRUG

Efimosfermin alfa to be administered

Efimosfermin alfa in participants of Chinese Ancestry; Efimosfermin alfa in participants of Japanese Ancestry; Efimosfermin alfa in participants of White/European Ancestry

Placebo DRUG

Placebo to be administered

Placebo in participants of Chinese Ancestry; Placebo in participants of Japanese Ancestry; Placebo in participants of White/European Ancestry

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who are generally healthy as determined by medical evaluation
• Body weight at least 50.0 Kilogram (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 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, (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 (that is \[i.e.\], from the original peoples of Europe) irrespective of place of birth or current place of residence.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Auckland, 1010, New Zealand

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double blinded study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): September 4, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

NZ (1)