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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05255094
Other study ID # AK102-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 3, 2021
Est. completion date July 31, 2022

Study information

Verified date February 2022
Source Akeso
Contact Guoqin Wang, MD
Phone +86 (0760) 8987 3999
Email global.trials@akesobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled phase Ⅲ clinical study evaluating the efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.


Description:

This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date July 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Subject understand and voluntarily sign the written Inform Consent Form (ICF). 2. Male or female = 18 to = 80 years of age. 3. The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment. 4. TG = 4.5 mmol/L (400 mg/dl). Exclusion Criteria: 1. Known homozygous familial hypercholesterolemia. 2. Received PCSK9 inhibitors within 6 months before randomization. 3. Known sensitivity to PCSK9 inhibitors and any substances to be administered. 4. Severe renal dysfunction. 5. Previously received organ transplantation. 6. Uncontrolled hypothyroidism or hyperthyroidism. 7. Uncontrolled hypertension. 8. Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc. 9. History of malignancy of any organ system within the past 5 years. 10. Pregnant or lactating women.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AK102
Administered AK102 by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
AK102
Administered AK102 by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
Drug:
Placebo
Administered placebo by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
Placebo
Administered placebo by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Locations

Country Name City State
China Peking University First Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage change from baseline of serum LDL-C level Percentage change from baseline of serum LDL-C level At week 12
Secondary Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL- Week 0-12
Secondary The incidence and severity of adverse events (AE) The incidence and severity of adverse events (AE) Week 0-12
Secondary To evaluate the population pharmacokinetic (PK) characteristics of AK102,such as AK102 concentration To evaluate the population pharmacokinetic (PK) characteristics of AK102,such as AK102 concentration Week 0-12
Secondary Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity Week 0-12
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