HypercholesterolemiaPhase 3NCT06717360
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R
A Phase 3 study testing AG2304T and AG2304R in people with Hypercholesterolemia, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- AG2304T and AG2304R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2024to 12 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19-80
- Patients with primary hypercholesterolemia
- Those who voluntarily written consent to participate in this clinical trial
Who cannot join
- The subject not meet the specified LDL-C level
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blinded, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients With Primary Hypercholesterolemia
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia
- Conditions
- Hypercholesterolemia
- Being tested
- AG2304T, AG2304R
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG2304TDrug
AG2304T, QD, PO
AG2304RDrug
AG2304R, QD, PO
| Study group | Role | What they receive |
|---|---|---|
| AG2304T | Experimental | Not described Receives: Drug: AG2304T |
| AG2304R | Active comparator | Not described Receives: Drug: AG2304R |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start30 Sep 2024
- Primary completion10 Jul 2025
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717360
- Sponsor's protocol ID
- AG2304 P3
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT06717360
- Acronym / sponsor ID
- AG2304 P3
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AG2304T | Experimental | Drug: AG2304T |
| AG2304R | Active comparator | Drug: AG2304R |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 19-80
- Patients with primary hypercholesterolemia
- Those who voluntarily written consent to participate in this clinical trial
Key exclusion criteria (2 listed)
- The subject not meet the specified LDL-C level
- Other exclusions applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG2304TAG2304T, QD, PO | Drug | AG2304T |
| AG2304RAG2304R, QD, PO | Drug | AG2304R |
Primary outcome
LDL-C level
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AG2304T and AG2304R in people with Hypercholesterolemia, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.