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A Study to Evaluate the Efficacy and Safety of Co-administration of AD-2281 and AD-2282

A Randomized, Double-blind, Active-controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combined Administration of AD-2281 and AD-2282 in Patients With Primary Hypercholesterolemia.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06747936
Enrollment
129
Registered
2024-12-24
Start date
2025-02-03
Completion date
2025-05-30
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolemia

Brief summary

The purpose of this study is to evaluate the efficacy and safetyof co-administration of AD-2281 and AD-2282 in patients with Primary Hypercholesterolemia

Interventions

DRUGAD-2281

PO, Once daily, 8weeks

DRUGAD-2282

PO, Once daily, 8weeks

DRUGPlacebo of AD-2282

PO, Once daily, 8weeks

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Signed informed consent * Patients with Primary Hypercholesterolemia * Other inclusions applied

Exclusion criteria

* Patients with Secondary Hypercholesterolemia * Other exclusions applied

Design outcomes

Primary

MeasureTime frameDescription
Change rate of LDL-Cfrom baseline at 8 weeksPercent change (%) of LDL-C from baseline at week 8

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026