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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05260411
Other study ID # AK102-302
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 26, 2022
Est. completion date December 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 # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia.


Description:

This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102 Q6W, 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 240
Est. completion date December 31, 2022
Est. primary completion date June 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AK102
Administered AK102 450 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
AK102
Administered AK102 600 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
Drug:
Placebo
Administered placebo by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Locations

Country Name City State
China The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
China Zhongshan Hospital, Fudan Hospital Shanghai

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 At week 12
Secondary Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels Week 0-24
Secondary The incidence and severity of adverse events (AE) Week 0-24
Secondary Evaluate the changes of AK102 PK parameters(t1/2) Week 0-24
Secondary Evaluate the changes of AK102 PK parameters(AUC) Week 0-24
Secondary Evaluate the changes of AK102 PK parameters(Vd) Week 0-24
Secondary Evaluate the changes of AK102 PK parameters(Tmax) Week 0-24
Secondary Evaluate the changes of free PCSK9 concentration Week 0-24
Secondary Evaluate the changes of AK102 PK parameters(Cmax) Week 0-24
Secondary Evaluate the changes of AK102 PK parameters(CL) Week 0-24
Secondary Evaluate the changes of AK102 PK parameters(MRT) Week 0-24
Secondary The number and percentage of anti AK102 antibody (ADA)positive subjects Week 0-24
Secondary The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects Week 0-24
Secondary the time of ADA positive Week 0-24
Secondary the time of nab positive Week 0-24
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