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NCT07335198CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (actual)
First submitted
5 Jan 2026
Start date
5 Mar 2026
Primary completion date
13 Aug 2026
Lead sponsor
GlaxoSmithKline
NCT number
NCT07335198

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 30
  • From 5 Mar 2026 to the primary completion date, 13 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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.
  • 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.
  • Known bleeding disorder.
  • History of immunodeficiency diseases, including a positive test result for human immunodeficiency virus (HIV).
  • Use of statins, other lipid lowering medications or hypertension medications unless on a stable dose for at least 3 months.

Lab values

  • Alanine transaminase (ALT) more than (\>)1.5 \* upper limit of normal (ULN).
  • Total bilirubin \>1.5 \* ULN
  • 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.

Other

  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.