Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2026-03-27
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (how the drug moves through the body), and immune response of a drug called efimosfermin alfa in healthy adults of Chinese, Japanese, and White/European ancestry. This study is a Phase 1, randomized, placebo-controlled, double-blind trial designed as a first time in Asia (FTIA) study to gather important safety and drug behavior data from these specific populations. Participants will be randomly assigned to receive a single dose of either efimosfermin alfa or a placebo. The study groups include healthy adults of Chinese, Japanese, and White/European backgrounds, each group receiving either the active drug or placebo. The study will closely monitor participants after dosing to evaluate drug levels and immune responses up to 90 days. During the study, participants will undergo medical evaluations, including blood tests, urine tests, vital signs monitoring, and heart rhythm assessments using electrocardiograms (ECGs). Researchers will track adverse events and measure drug concentration levels over time to understand how the drug is processed in the body. The total study period for each participant is up to 90 days, during which safety and pharmacokinetic data will be collected and analyzed.
CONDITIONS
Brief 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 adults as confirmed 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
- 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 with specified Japanese lineage and lived outside Japan for less than 10 years
- White/European ancestry participants self-identified with at least 2 parents and 4 grandparents of White/European descent
You will not qualify if you...
- History or presence of conditions affecting drug absorption, metabolism, or elimination
- Current or chronic liver or biliary disease except Gilbert's syndrome or asymptomatic gallstones
- History of pancreatic disease, Type 1 diabetes, or serious Type 2 diabetes complications
- Abnormal blood pressure (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- History of metabolic bone disorders like osteoporosis or osteopenia
- History of cancer (except localized basal cell carcinoma) within past 5 years
- Elevated liver enzymes (ALT >1.5 times normal) or bilirubin >1.5 times normal
- Known bleeding disorders
- History of immunodeficiency including positive HIV test
- Prolonged corrected QT interval on ECG (≥450 ms males, ≥470 ms females)
- Use of statins, lipid-lowering or hypertension drugs unless stable for 3 months
- Use of other investigational drugs recently or FGF21 analogs previously
- Use of medications including herbal within 7 days prior to dosing
- Recent live or non-live vaccinations
- Participation in another trial within 30 days before consent
- Positive tests for hepatitis B or C
- Positive drug or alcohol screening prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days
Participants receive a single dose of Efimosfermin alfa or placebo and are monitored for safety and drug effects.
Multiple visits over 90 days for safety and pharmacokinetic assessments
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
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here