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

Last updated: March 4, 2025
Sponsor: Akeso
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Elevated Triglycerides (Hypertriglyceridemia)

Dyslipidemia

Treatment

Placebo

AK102

Clinical Study ID

NCT05255094
AK102-301
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 atleast 4 weeks of stable lipid-lowering background treatment.

  4. TG ≤ 4.5 mmol/L (400 mg/dl).

Exclusion

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.

Study Design

Total Participants: 464
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 03, 2021
Estimated Completion Date:
June 22, 2022

Study 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.

Connect with a study center

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.