NIPH Clinical Trials Search

Real-world study of evinacmab

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Homozygous Familial Hypercholesterolemia
Date of first enrollment	11/11/2025
Target sample size	40
Countries of recruitment	N A,Japan
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

To evaluate the incidence and severity of adverse events in patients with homozygous familial hypercholesterolemia (HoFH) receiving intravenous evinacumab (15 mg/kg) every four weeks. Additionally, to assess the efficacy of evinacumab based on changes in LDL cholesterol levels following administration.

Secondary Outcome

1. Descriptive evaluation of the clinical status of patients treated with evinacumab, including performed examinations, concomitant medications, combination therapies, comorbidities and medical history, and physical findings. 2. Descriptive evaluation of changes in concomitant medications and combination therapies following administration of evinacumab. 3. Descriptive evaluation of changes in cardiovascular lesions (e.g., carotid intima-media thickness [IMT], cardiovascular imaging findings) after evinacumab administration. 4. Descriptive evaluation of changes in clinical laboratory values following evinacumab administration. 5. Descriptive evaluation of changes in xanthomas after evinacumab administration. 6. Descriptive evaluation of the safety and efficacy of evinacumab based on genotype, age, sex, and treatment background.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender
Include criteria	Patients with homozygous familial hypercholesterolemia treated with evinacumab
Exclude criteria	Patients who did not provide consent to participate in the study, except at institutions that adopted opt-out procedures.