A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia

Hyperlipidemia Clinical Trial

Official title:

A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260411
• Other study ID #: AK102-302
• Status: Recruiting
• Phase: Phase 3
• Start date: January 26, 2022
• Est. completion date: December 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 # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia.

Description:

This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102 Q6W, 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: 240
• Est. completion date: December 31, 2022
• 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).

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Biological:
• AK102
Administered AK102 450 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
• AK102
Administered AK102 600 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Drug:
• Placebo
Administered placebo by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhongshan Hospital, Fudan Hospital	Shanghai

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		At week 12
Secondary	Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels		Week 0-24
Secondary	The incidence and severity of adverse events (AE)		Week 0-24
Secondary	Evaluate the changes of AK102 PK parameters(t1/2)		Week 0-24
Secondary	Evaluate the changes of AK102 PK parameters(AUC)		Week 0-24
Secondary	Evaluate the changes of AK102 PK parameters(Vd)		Week 0-24
Secondary	Evaluate the changes of AK102 PK parameters(Tmax)		Week 0-24
Secondary	Evaluate the changes of free PCSK9 concentration		Week 0-24
Secondary	Evaluate the changes of AK102 PK parameters(Cmax)		Week 0-24
Secondary	Evaluate the changes of AK102 PK parameters(CL)		Week 0-24
Secondary	Evaluate the changes of AK102 PK parameters(MRT)		Week 0-24
Secondary	The number and percentage of anti AK102 antibody (ADA)positive subjects		Week 0-24
Secondary	The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects		Week 0-24
Secondary	the time of ADA positive		Week 0-24
Secondary	the time of nab positive		Week 0-24