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COMPLETEDPHASE2

A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of AK102 in Patients With Heterozygous Familial Hypercholesterolemia

NCT04173793•Akeso

View on ClinicalTrials.gov

Summary

This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to evaluate the efficacy of AK102 in patients with HeFH.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with heterozygous familial hypercholesterolemia diagnosed by genetic confirmation or clinical diagnosis criteria.
•Stable on pre-existing, lipid-lowering therapies (statins with or without ezetimibe) for at least 4 weeks with no planned medication or dose change for the duration of study participation.
•Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 70 mg/dL in patients with history of Atherosclerotic Cardiovascular Disease (ASCVD) or Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL in patients without history of Atherosclerotic Cardiovascular Disease (ASCVD).
•Fasting triglycerides ≤ 400 mg/dL.
•Body weight ≥ 40kg.

Exclusion Criteria

•Subjects with homozygous FH (clinically or by genotyping).
•Receipt of LDL apheresis within 12 months prior to the first dose of Investigational product.
•Receipt of Lomitapide or Mipomersen within 5 months prior to the first dose of Investigational product.
•Prior use of PCSK9 inhibitors.
•Creatine kinase (CK) \>3 times of the upper limit of normal (ULN).
•Aspartate Aminotransferase (AST) ≥ 2 x ULN.
•Estimated Glomerular Filtration Rate (eGFR)≤ 30 mL/min/1.73m\^2.
•Thyroid-Stimulating Hormone (TSH)\> 1.5 x ULN or \<1 x LLN.
•Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c\> 8.5%).
•Subjects with untreated or active chronic hepatitis B or active hepatitis C virus infections.

Locations (2)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, China

Key Dates

Start Date

November 18, 2019

Primary Completion Date

September 26, 2022

Completion Date

September 26, 2022

Last Updated

March 2, 2023

Enrollment

109

ACTUAL participants

Conditions

Heterozygous Familial Hypercholesterolemia

Interventions

AK102

DRUG

Placebo

DRUG

Statins and/or Ezetimibe

DRUG

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

NCT07058077

Heterozygous Familial Hypercholesterolemia (HeFH)

View study

RECRUITINGPHASE3

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

NCT06568471

HypercholesterolemiaDyslipidemias+5 more

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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.

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A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

Inclusion Criteria

Exclusion Criteria

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)

A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)

Exploratory Study of Plaque Regression