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

Phase 3

Not yet recruiting

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: AD-2281; Drug: AD-2282; Drug: Placebo of AD-2282

• Registration Number: NCT06747936
• Lead Sponsor: Addpharma Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-24
• Status Verified: 2025-02
• Study Start: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

• Patients with Secondary Hypercholesterolemia
• Other exclusions applied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AD-2281 + AD-2282	AD-2281	-
AD-2281 + AD-2282	AD-2282	-
AD-2281 + Placebo of AD-2282	AD-2281	-
AD-2281 + Placebo of AD-2282	Placebo of AD-2282	-

Primary Outcome Measures

Name	Time	Method
Change rate of LDL-C	from baseline at 8 weeks	Percent change (%) of LDL-C from baseline at week 8