Clinical trial NCT05255458: A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia
Official title: A Phase 3 Clinical Study Evaluating the Long-term Efficacy and Safety of AK102 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: 2022-02-24
Enrollment: 122
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 3 clinical study evaluating the long-term efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.

Detailed description: This is a Phase 3 clinical study to evaluate the long-term efficacy and safety of AK102, 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), which must be signed before performing the study procedures.
2. Male or female patients aged between 18 and 80 years (including upper and lower limits).
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. Triglyceride ≤ 4.5 mmol/L (400 mg/dl).

Exclusion Criteria:

1. Homozygous Familial Hypercholesterolemia (HoFH).
2. Received PCSK9 inhibitors within 6 months before randomization.
3. Known sensitivity to PCSK9 inhibitors and any substances to be administered.
4. Severe liver and 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.

Primary outcomes:
measure: Precentage change from baseline of serum LDL-C level
timeFrame: At week 52
measure: The incidence and severity of adverse events (AE)
timeFrame: Week 0-52
Secondary outcomes:
measure: Value and percentage change from baseline of serum TC levels
timeFrame: Week 0-52
measure: Value and percentage change from baseline of serum TG levels
timeFrame: Week 0-52
measure: Value and percentage change from baseline of serum non HDL-C levels
timeFrame: Week 0-52
measure: Value and percentage change from baseline of serum ApoB levels
timeFrame: Week 0-52
measure: Value and percentage change from baseline of serum HDL-C levels
timeFrame: Week 0-52
measure: Value and percentage change from baseline of serum ApoA-I levels
timeFrame: Week 0-52
measure: Value and percentage change from baseline of serum Lp(a) levels
timeFrame: Week 0-52
measure: Evaluate the population pharmacokinetic (PK) characteristics of AK102 , such as AK102 concentration
timeFrame: Week 0-52
measure: Number and percentage of subjects with positive anti-AK102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity
timeFrame: Week 0-52
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
Study officials:
References: