Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2026-03-27
30
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Generally healthy as determined by medical evaluation
- Body weight at least 50 kg for males or 45 kg for females
- Body mass index (BMI) between 18.0 and 28.0 kg/m2 inclusive
- Male and female participants
- Chinese ancestry participants born in mainland China, Hong Kong, or Taiwan, and lived outside these areas for less than 10 years
- Japanese ancestry participants born in Japan, descendants of 2 ethnic Japanese parents and 4 grandparents, and lived outside Japan for less than 10 years
- White/European ancestry participants self-identified as White/European, descendants of 2 parents and 4 grandparents of White/European ancestry
You will not qualify if you...
- History or presence of disorders affecting drug absorption, metabolism, or elimination
- Current or chronic liver or biliary disease except Gilbert's syndrome or asymptomatic gallstones
- History of pancreatic injury, pancreatitis, pancreatic disease, Type 1 Diabetes Mellitus, or major Type 2 Diabetes Mellitus complications
- Abnormal blood pressure: systolic ≥140 mmHg or diastolic ≥90 mmHg
- History of metabolic bone disorders such as osteoporosis, osteopenia, or osteomalacia
- History of malignancy within the past 5 years except localized basal cell carcinoma
- Alanine transaminase (ALT) >1.5 times upper limit of normal
- Total bilirubin >1.5 times upper limit of normal
- Known bleeding disorders
- History of immunodeficiency diseases including HIV
- Corrected QT Interval (QTcF) ≥450 ms (male) or ≥470 ms (female) at screening
- Use of statins, lipid-lowering, or hypertension medications unless stable for at least 3 months
- Use of investigational drugs at enrollment or within required washout periods
- Prior use of native FGF21 or FGF21 analog
- Use of any medication including herbal within 7 days prior to dosing and during study
- Live vaccine within 14 days prior to dosing or non-live vaccines within 7 days prior
- Participation in another clinical trial within 30 days before consent
- Presence of hepatitis B surface antigen or hepatitis C antibody at screening or within 3 months
- Positive drug or alcohol screen before study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
GSK Investigational Site
Auckland, New Zealand, 1010
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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