Clinical trial NCT05260411: A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia
Official title: A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage change from baseline of serum LDL-C level
timeFrame: At week 12
Secondary outcomes:
measure: Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels
timeFrame: Week 0-24
measure: The incidence and severity of adverse events (AE)
timeFrame: Week 0-24
measure: Evaluate the changes of AK102 PK parameters(t1/2)
timeFrame: Week 0-24
measure: Evaluate the changes of AK102 PK parameters(AUC）
timeFrame: Week 0-24
measure: Evaluate the changes of AK102 PK parameters(Vd)
timeFrame: Week 0-24
measure: Evaluate the changes of AK102 PK parameters(Tmax)
timeFrame: Week 0-24
measure: Evaluate the changes of free PCSK9 concentration
timeFrame: Week 0-24
measure: Evaluate the changes of AK102 PK parameters(Cmax)
timeFrame: Week 0-24
measure: Evaluate the changes of AK102 PK parameters(CL)
timeFrame: Week 0-24
measure: Evaluate the changes of AK102 PK parameters(MRT)
timeFrame: Week 0-24
measure: The number and percentage of anti AK102 antibody (ADA)positive subjects
timeFrame: Week 0-24
measure: The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects
timeFrame: Week 0-24
measure: the time of ADA positive
timeFrame: Week 0-24
measure: the time of nab positive
timeFrame: Week 0-24
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan Hospital
Study officials:
References: