A Study to Evaluate the 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

NCT05255094

AK102-301

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the 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 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: 464 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).
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

464 participants in 4 patient groups, including a placebo group

AK102 regimen 1

Experimental group

Treatment:

Biological: AK102

Biological: AK102

AK102 regimen 2

Experimental group

Treatment:

Biological: AK102

Biological: AK102

Placebo 1

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Placebo 2

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo