NCT06717360

Brief Summary

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2026

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

November 28, 2024

Last Update Submit

June 16, 2026

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • LDL-C level

    8 weeks

Study Arms (2)

AG2304T

EXPERIMENTAL
Drug: AG2304T

AG2304R

ACTIVE COMPARATOR
Drug: AG2304R

Interventions

AG2304TDRUG

AG2304T, QD, PO

AG2304T
AG2304RDRUG

AG2304R, QD, PO

AG2304R

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 19-80
  • Patients with primary hypercholesterolemia
  • Those who voluntarily written consent to participate in this clinical trial

You may not qualify if:

  • The subject not meet the specified LDL-C level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AhnGook

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional 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

November 28, 2024

First Posted

December 5, 2024

Study Start

September 30, 2024

Primary Completion

July 10, 2025

Study Completion

May 12, 2026

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations

KR(1)