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Clinical Trials/NCT05260411
NCT05260411CompletedPhase 3

A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Akeso2 sites in 1 country246 target enrollmentStarted: January 26, 2022Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
246
Locations
2
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 # clinical study evaluating the efficacy and safety of AK102 Q6W 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 Q6W, 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.

Arms & Interventions

AK102 regimen 1

Experimental

Intervention: AK102 (Biological)

AK102 regimen 2

Experimental

Intervention: AK102 (Biological)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Percentage change from baseline of serum LDL-C level

Time Frame: At week 12

Secondary Outcomes

  • Evaluate the changes of AK102 PK parameters(Tmax)(Week 0-24)
  • Evaluate the changes of AK102 PK parameters(Vd)(Week 0-24)
  • Evaluate the changes of AK102 PK parameters(t1/2)(Week 0-24)
  • The number and percentage of anti AK102 antibody (ADA)positive subjects(Week 0-24)
  • the time of nab positive(Week 0-24)
  • Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels(Week 0-24)
  • The incidence and severity of adverse events (AE)(Week 0-24)
  • Evaluate the changes of AK102 PK parameters(AUC）(Week 0-24)
  • Evaluate the changes of free PCSK9 concentration(Week 0-24)
  • Evaluate the changes of AK102 PK parameters(Cmax)(Week 0-24)
  • Evaluate the changes of AK102 PK parameters(CL)(Week 0-24)
  • Evaluate the changes of AK102 PK parameters(MRT)(Week 0-24)
  • The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects(Week 0-24)
  • the time of ADA positive(Week 0-24)

Investigators

Sponsor
Akeso
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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