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

Sponsor
GlaxoSmithKline
Study ID
NCT07335198
Phase
PHASE1
Status
Recruiting
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Conditions

  • Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Efimosfermin alfa — DRUG
    Efimosfermin alfa to be administered
  • Placebo — DRUG
    Placebo to be administered

Study Details

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.

Key Dates

First listed
Jan 13, 2026
Start date
Mar 5, 2026
Status verified
Mar 2026
Primary completion
Aug 17, 2026
Completion
Aug 17, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efimosfermin alfa in participants of Chinese Ancestry
    Healthy participants of Chinese ancestry will be randomized to receive efimosfermin alfa.
  • Experimental: Efimosfermin alfa in participants of Japanese Ancestry
    Healthy participants of Japanese ancestry will be randomized to receive efimosfermin alfa.
  • Experimental: Efimosfermin alfa in participants of White/European Ancestry
    Healthy participants of White/European ancestry will be randomized to receive efimosfermin alfa
  • Placebo Comparator: Placebo in participants of Chinese Ancestry
    Healthy participants of Chinese ancestry will be randomized to receive Placebo.
  • Placebo Comparator: Placebo in participants of Japanese Ancestry
    Healthy participants of Japanese ancestry will be randomized to receive Placebo.
  • Placebo Comparator: Placebo in participants of White/European Ancestry
    Healthy participants of White/European ancestry will be randomized to receive Placebo.

Primary Outcome Measure

Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs) [ Time Frame: Up to 90 days ]

Central Contacts

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