CompletedPhase 3

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

China122 participantsStarted 2021-11-04

Plain-language 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.

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), which must be signed before performing the study procedures.
✓. Male or female patients aged between 18 and 80 years (including upper and lower limits).
✓. 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.
✓. Triglyceride ≤ 4.5 mmol/L (400 mg/dl).

Exclusion criteria

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

Precentage change from baseline of serum LDL-C level

Timeframe: At week 52

The incidence and severity of adverse events (AE)

Timeframe: Week 0-52

Trial details

NCT IDNCT05255458

SponsorAkeso

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-09

View on ClinicalTrials.gov More Hyperlipidemia trials