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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04173793
Other study ID # AK102-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 18, 2019
Est. completion date September 26, 2022

Study information

Verified date March 2023
Source Akeso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date September 26, 2022
Est. primary completion date September 26, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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. Key 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AK102
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Statins and/or Ezetimibe
Lipid-lowering therapies

Locations

Country Name City State
China Beijing Anzhen Hospital Beijing Beijing
China Peking Union Medical College Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Akeso AD Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 12 At baseline and week 12
Secondary Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) From baseline through 12 weeks
Secondary Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) From baseline through 12 weeks
Secondary Percent change from baseline in non High-density lipoprotein (non-HDL) cholesterol From baseline through 12 weeks
Secondary Percent change from baseline in serum Triglyceride (TG) cholesterol From baseline through 12 weeks
Secondary Percent change from baseline in Apolipoprotein B (Apo B) From baseline through 12 weeks
Secondary Percent change from baseline in Apolipoprotein A-I (ApoA-I) From baseline through 12 weeks
Secondary Percent change from baseline in Lipoprotein(a) [Lp-(a)] From baseline through 12 weeks
Secondary Percent change from baseline in Total Cholesterol(TC) From baseline through 12 weeks
Secondary Incidence of treatment-emergent adverse events From baseline through 12 weeks
Secondary Serum concentrations of AK102 From baseline through 12 weeks
Secondary Number of subjects who develop detectable anti-drug antibodies (ADAs) The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies. From baseline through 12 weeks
Secondary Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) From baseline through 12 weeks
See also
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