CompletedPhase 3

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

China464 participantsStarted 2021-11-03

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Subject understand and voluntarily sign the written Inform Consent Form (ICF).
✓. Male or female ≥ 18 to ≤ 80 years of age.
✓. 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.
✓. TG ≤ 4.5 mmol/L (400 mg/dl).

Exclusion criteria

✕. Known homozygous familial hypercholesterolemia.
✕. Received PCSK9 inhibitors within 6 months before randomization.
✕. Known sensitivity to PCSK9 inhibitors and any substances to be administered.
✕. Severe renal dysfunction.
✕. Previously received organ transplantation.
✕. Uncontrolled hypothyroidism or hyperthyroidism.
✕. Uncontrolled hypertension.
✕. Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.

What they're measuring

Percentage change from baseline of serum LDL-C level

Timeframe: At week 12

Trial details

NCT IDNCT05255094

SponsorAkeso

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-22

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