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Clinical Trials/NCT05255094
NCT05255094CompletedPhase 3

A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Akeso1 site in 1 country464 target enrollmentStarted: November 3, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
464
Locations
1
Primary Endpoint
Percentage change from baseline of serum LDL-C level
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • •History of malignancy of any organ system within the past 5 years.
  • •Pregnant or lactating women.

Arms & Interventions

AK102 regimen 2

Experimental

Intervention: AK102 (Biological)

AK102 regimen 1

Experimental

Intervention: AK102 (Biological)

Placebo 1

Placebo Comparator

Intervention: Placebo (Drug)

Placebo 2

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Percentage change from baseline of serum LDL-C level

Time Frame: At week 12

Percentage change from baseline of serum LDL-C level

Secondary Outcomes

  • Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels(Week 0-12)
  • The incidence and severity of adverse events (AE)(Week 0-12)
  • To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration(Week 0-12)
  • Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity(Week 0-12)

Investigators

Sponsor
Akeso
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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