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

NCT05255094 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

AK102

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

BIOLOGICAL

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

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2022-06-22
Completion
2022-06-22

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255094 on ClinicalTrials.gov