Hyperlipidemia
Conditions
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.
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.
Interventions
BIOLOGICALAK102
Administered AK102 by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies
DRUGPlacebo
Administered placebo by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Precentage change from baseline of serum LDL-C level | At week 52 |
| The incidence and severity of adverse events (AE) | Week 0-52 |
Secondary
| Measure | Time frame |
|---|---|
| Value and percentage change from baseline of serum non HDL-C levels | Week 0-52 |
| Value and percentage change from baseline of serum ApoB levels | Week 0-52 |
| Value and percentage change from baseline of serum HDL-C levels | Week 0-52 |
| Value and percentage change from baseline of serum TC levels | Week 0-52 |
| Value and percentage change from baseline of serum Lp(a) levels | Week 0-52 |
| Evaluate the population pharmacokinetic (PK) characteristics of AK102 , such as AK102 concentration | Week 0-52 |
| Number and percentage of subjects with positive anti-AK102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity | Week 0-52 |
| Value and percentage change from baseline of serum ApoA-I levels | Week 0-52 |
| Value and percentage change from baseline of serum TG levels | Week 0-52 |
Countries
China
Outcome results
None listed