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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255458
• Other study ID #: AK102-303
• Status: Recruiting
• Phase: Phase 3
• Start date: November 4, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2022
• Source: Akeso
• Contact: Guoqin Wang, MD
• Phone: +86(0760)89873999
• Email: global.trials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: January 31, 2023
• Est. primary completion date: June 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), 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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

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

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

Locations

Country	Name	City	State
China	The Third Hospital of Nanchang	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precentage change from baseline of serum LDL-C level		At week 52
Primary	The incidence and severity of adverse events (AE)		Week 0-52
Secondary	Value and percentage change from baseline of serum TC levels		Week 0-52
Secondary	Value and percentage change from baseline of serum TG levels		Week 0-52
Secondary	Value and percentage change from baseline of serum non HDL-C levels		Week 0-52
Secondary	Value and percentage change from baseline of serum ApoB levels		Week 0-52
Secondary	Value and percentage change from baseline of serum HDL-C levels		Week 0-52
Secondary	Value and percentage change from baseline of serum ApoA-I levels		Week 0-52
Secondary	Value and percentage change from baseline of serum Lp(a) levels		Week 0-52
Secondary	Evaluate the population pharmacokinetic (PK) characteristics of AK102 , such as AK102 concentration		Week 0-52
Secondary	Number and percentage of subjects with positive anti-AK102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity		Week 0-52