Clincosm LogoSign in Get a demo

A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia

Sponsor
Akeso (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05260411
Collaborator
(none)
240
Enrollment
2
Locations
3
Arms
11.1
Anticipated Duration (Months)
120
Patients Per Site
10.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: AK102
  • Biological: AK102
  • Drug: Placebo
 Phase 3

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
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
Actual Study Start Date :
Jan 26, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AK102 regimen 1

Biological: AK102
Administered AK102 450 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
Experimental: AK102 regimen 2

Biological: AK102
Administered AK102 600 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
Placebo Comparator: Placebo

Drug: Placebo
Administered placebo by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Outcome Measures

Primary Outcome Measures

  1. Percentage change from baseline of serum LDL-C level [At week 12]

Secondary Outcome Measures

  1. 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]

  2. The incidence and severity of adverse events (AE) [Week 0-24]

  3. Evaluate the changes of AK102 PK parameters(t1/2) [Week 0-24]

  4. Evaluate the changes of AK102 PK parameters(AUC） [Week 0-24]

  5. Evaluate the changes of AK102 PK parameters(Vd) [Week 0-24]

  6. Evaluate the changes of AK102 PK parameters(Tmax) [Week 0-24]

  7. Evaluate the changes of free PCSK9 concentration [Week 0-24]

  8. Evaluate the changes of AK102 PK parameters(Cmax) [Week 0-24]

  9. Evaluate the changes of AK102 PK parameters(CL) [Week 0-24]

  10. Evaluate the changes of AK102 PK parameters(MRT) [Week 0-24]

  11. The number and percentage of anti AK102 antibody (ADA)positive subjects [Week 0-24]

  12. The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects [Week 0-24]

  13. the time of ADA positive [Week 0-24]

  14. the time of nab positive [Week 0-24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 at least 4 weeks of stable lipid-lowering background treatment.

  4. TG ≤ 4.5 mmol/L (400 mg/dl)

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China
2 Zhongshan Hospital, Fudan Hospital Shanghai China

Sponsors and Collaborators

  • Akeso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akeso
ClinicalTrials.gov Identifier:
NCT05260411
Other Study ID Numbers:
  • AK102-302
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias

Study Results

No Results Posted as of Mar 2, 2022