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

NCT05260411 | Completed Phase 3

• 1 other identifier: AK102-302
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline of serum LDL-C level

  At week 12

Secondary Outcomes (14)

• 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

• The incidence and severity of adverse events (AE)

  Week 0-24

• Evaluate the changes of AK102 PK parameters(t1/2)

  Week 0-24

• Evaluate the changes of AK102 PK parameters(AUC）

  Week 0-24

• Evaluate the changes of AK102 PK parameters(Vd)

  Week 0-24

Study Arms (3)

AK102 regimen 1

EXPERIMENTAL

Biological: AK102

AK102 regimen 2

EXPERIMENTAL

Biological: AK102

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AK102 BIOLOGICAL

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

AK102 regimen 1

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Zhongshan Hospital, Fudan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 2, 2022
• Study Start: January 26, 2022
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (2)