A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia

Akeso

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: Placebo; Biological: AK102

Study type: Interventional

Funder types: Industry

Identifiers

NCT05255458

AK102-303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups, including a placebo group

AK102 regimen 1

Experimental group

Treatment:

Biological: AK102

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo