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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255094
• Other study ID #: AK102-301
• Status: Recruiting
• Phase: Phase 3
• Start date: November 3, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2022
• Source: Akeso
• Contact: Guoqin Wang, MD
• Phone: +86 (0760) 8987 3999
• Email: global.trials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

10. Pregnant or lactating women.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Biological:
• AK102
Administered AK102 by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
• AK102
Administered AK102 by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Drug:
• Placebo
Administered placebo by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
• Placebo
Administered placebo by subcutaneous injection every 4 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline of serum LDL-C level	Percentage change from baseline of serum LDL-C level	At week 12
Secondary	Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels	Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-	Week 0-12
Secondary	The incidence and severity of adverse events (AE)	The incidence and severity of adverse events (AE)	Week 0-12
Secondary	To evaluate the population pharmacokinetic (PK) characteristics of AK102,such as AK102 concentration	To evaluate the population pharmacokinetic (PK) characteristics of AK102,such as AK102 concentration	Week 0-12
Secondary	Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity	Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity	Week 0-12