A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia
NCT05255458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2025-02-28
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.
Conditions
Interventions
- BIOLOGICAL
-
AK102
Administered AK102 by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies
- DRUG
-
Administered placebo by subcutaneous injection Drug: Statins and/or Ezetimibe lipid-lowering therapies
Sponsors & Collaborators
- lead INDUSTRY
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
- 2021-11-04
- Primary Completion
- 2023-01-09
- Completion
- 2023-01-09
Countries
- China
Study Locations
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