A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia
Study Details
Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled phase Ⅲ clinical study evaluating the efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AK102 regimen 1
|
Biological: AK102
Administered AK102 by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
|
| Experimental: AK102 regimen 2
|
Biological: AK102
Administered AK102 by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
|
| Placebo Comparator: Placebo 1
|
Drug: Placebo
Administered placebo by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
|
| Placebo Comparator: Placebo 2
|
Drug: Placebo
Administered placebo by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
|
Outcome Measures
Primary Outcome Measures
- Percentage change from baseline of serum LDL-C level [At week 12]
Percentage change from baseline of serum LDL-C level
Secondary Outcome Measures
- Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels [Week 0-12]
Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-
- The incidence and severity of adverse events (AE) [Week 0-12]
The incidence and severity of adverse events (AE)
- To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration [Week 0-12]
To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration
- Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity [Week 0-12]
Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | China |
Sponsors and Collaborators
- Akeso
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AK102-301