Loading clinical trials...

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH

A Phase 2 Study to Evaluate the Safety and Efficacy of PCSK9 Inhibitor AK102 in Patients With Homozygous Familial Hypercholesterolemia (HoFH)

NCT03933293•Akeso

View on ClinicalTrials.gov

Summary

AK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double blind, randomized, placebo controlled study to evaluate the efficacy and safety of PCSK9 inhibitor AK102. The treatment period will last 12 week.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females, ≥18 years of age with a diagnosis of homozygous familial hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a history of an untreated low-density lipoprotein cholesterol (LDL-C) concentration \>500 mg/deciliter (dL) \[13 millimoles/liter (mmol/L)\] together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents
•Stable on pre-existing, lipid-lowering therapies (statins in combination with ezetimibe) for at least 4 weeks with no planned medication or dose change for the duration of study participation
•Fasting central lab LDL-C concentration \>130 mg/dL (3.4 mmol/L) and triglyceride concentration \<400 mg/dL (4.5 mmol/L).
•Body weight of 40 kilograms (kg) or greater at screening

Exclusion Criteria

•Received LDL plasma replacement therapy within 8 weeks before Investigational product administration
•Received Lomitapide or Mipomersen within 5 months before Investigational product administration
•Received prior treatment with PCSK9 inhibitors or AK102.
•Unexplained creatine kinase (CK) ≥ 5 times the upper limit of normal (ULN)
•Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA \<500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
•Known allergic reactions to any ingredients of AK102
•Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study as judged by the Investigator and/or Medical Monitor.

Locations (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 13, 2019

Primary Completion Date

March 15, 2021

Completion Date

March 15, 2021

Last Updated

March 2, 2023

Enrollment

ACTUAL participants

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

AK102

DRUG

Statins

DRUG

Ezetimibe

DRUG

The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

NCT01109368

Homozygous Familial Hypercholesterolemia

View study

ACTIVE_NOT_RECRUITING

Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia

NCT06832371

Homozygous Familial Hypercholesterolemia (HoFH)Major Adverse Cardiovascular Events (MACE)+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH

Inclusion Criteria

Exclusion Criteria

The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia

A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH)

Vytorin Reexamination Study (0653A-174)