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

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Biological: AK102; Drug: Placebo

• Registration Number: NCT05255094
• Lead Sponsor: Akeso

Brief Summary

This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the 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 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 Timeline

• Study Start: 2021-11-03
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK102 regimen 1	AK102	-
AK102 regimen 2	AK102	-
Placebo 1	Placebo	-
Placebo 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline of serum LDL-C level	At week 12	Percentage change from baseline of serum LDL-C level

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China