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

Sponsor
Akeso (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05255458
Collaborator
(none)
122
Enrollment
1
Location
2
Arms
14.9
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Detailed Description

This is a Phase 3 clinical study to evaluate the long-term 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
Anticipated Enrollment :
122 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 Long-term Efficacy and Safety of AK102 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
Actual Study Start Date :
Nov 4, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: AK102 regimen 1

Biological: AK102
Administered AK102 by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies
Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Precentage change from baseline of serum LDL-C level [At week 52]

  2. The incidence and severity of adverse events (AE) [Week 0-52]

Secondary Outcome Measures

  1. Value and percentage change from baseline of serum TC levels [Week 0-52]

  2. Value and percentage change from baseline of serum TG levels [Week 0-52]

  3. Value and percentage change from baseline of serum non HDL-C levels [Week 0-52]

  4. Value and percentage change from baseline of serum ApoB levels [Week 0-52]

  5. Value and percentage change from baseline of serum HDL-C levels [Week 0-52]

  6. Value and percentage change from baseline of serum ApoA-I levels [Week 0-52]

  7. Value and percentage change from baseline of serum Lp(a) levels [Week 0-52]

  8. Evaluate the population pharmacokinetic (PK) characteristics of AK102 , such as AK102 concentration [Week 0-52]

  9. Number and percentage of subjects with positive anti-AK102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity [Week 0-52]

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), which must be signed before performing the study procedures.

  2. Male or female patients aged between 18 and 80 years (including upper and lower limits).

  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. Triglyceride ≤ 4.5 mmol/L (400 mg/dl).

Exclusion Criteria:

  1. Homozygous Familial Hypercholesterolemia (HoFH).

  2. Received PCSK9 inhibitors within 6 months before randomization.

  3. Known sensitivity to PCSK9 inhibitors and any substances to be administered.

  4. Severe liver and 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.

  10. Pregnant or lactating women.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Third Hospital of Nanchang Nanchang Jiangxi China 330009

Sponsors and Collaborators

  • Akeso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akeso
ClinicalTrials.gov Identifier:
NCT05255458
Other Study ID Numbers:
  • AK102-303
First Posted:
Feb 24, 2022
Last Update Posted:
Feb 24, 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 Feb 24, 2022