HyperlipidemiaPhase 1NCT07730567
A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-236A and AD-236B
A Phase 1 study testing Treatment A(AD-236A), Treatment B(AD-236B) and Treatment C(AD-236A+AD-236B) in people with Hyperlipidemia and Diabete Type 2, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
To evaluate the pharmacokinetic interaction and the safety of AD-236A and AD-236B in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Diabete Type 2
- What is being tested?
- Treatment A(AD-236A), Treatment B(AD-236B) and Treatment C(AD-236A+AD-236B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2026to 26 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers aged ≥19 and ≤55 years at the time of the screening visit
- Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of the screening visit
Who cannot join
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
H+ Yangji Hospital, Seoul,
Seoul, 08779
Seunghyun Kang, +82-70-4665-9174, m4222@newyjh.com
About this study
Official title: A Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-236A and AD-236B in Healthy Adult Volunteers
To evaluate the pharmacokinetic interaction and the safety of AD-236A and AD-236B in healthy adult volunteers
- Conditions
- Hyperlipidemia, Diabete Type 2
- Being tested
- Treatment A(AD-236A), Treatment B(AD-236B), Treatment C(AD-236A+AD-236B)
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A(AD-236A)Drug
AD-236A Oral Tablet
Treatment B(AD-236B)Drug
AD-236B Oral Tablet
Treatment C(AD-236A+AD-236B)Drug
AD-236A+AD-236B Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Period 1 : Treatment A(AD-236A), Period 2 : Treatment C(AD-236A+AD-236B) Receives: Drug: Treatment A(AD-236A); Drug: Treatment C(AD-236A+AD-236B) |
| Arm B | Experimental | Period 1 : Treatment B(AD-236B), Period 2 : Treatment C(AD-236A+AD-236B) Receives: Drug: Treatment B(AD-236B); Drug: Treatment C(AD-236A+AD-236B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)
AUCτ,ss
Measured: pre-dose (0hour) to 24 hours post-dose
Maximum concentration of drug in plasma at steady state (Cmax,ss)
Cmax,ss
Measured: pre-dose (0hour) to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start29 Jul 2026 (estimated)
- Primary completion13 Sep 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730567
- Sponsor's protocol ID
- AD-236DDI
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-236A and AD-236B in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07730567
- Acronym / sponsor ID
- AD-236DDI
- Conditions
- Hyperlipidemia, Diabete Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2026 (estimated)
- Primary completion
- 13 Sep 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 28 Jul 2026 (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.
To evaluate the pharmacokinetic interaction and the safety of AD-236A and AD-236B in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Treatment A(AD-236A), Drug: Treatment C(AD-236A+AD-236B)Period 1 : Treatment A(AD-236A), Period 2 : Treatment C(AD-236A+AD-236B) |
| Arm B | Experimental | Drug: Treatment B(AD-236B), Drug: Treatment C(AD-236A+AD-236B)Period 1 : Treatment B(AD-236B), Period 2 : Treatment C(AD-236A+AD-236B) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult volunteers aged ≥19 and ≤55 years at the time of the screening visit
- Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of the screening visit
Key exclusion criteria (2 listed)
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- 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 |
|---|---|---|
| Treatment A(AD-236A)AD-236A Oral Tablet | Drug | Arm A |
| Treatment B(AD-236B)AD-236B Oral Tablet | Drug | Arm B |
| Treatment C(AD-236A+AD-236B)AD-236A+AD-236B Oral Tablet | Drug | Arm A, Arm B |
Primary outcome
1. Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)
Time frame: pre-dose (0hour) to 24 hours post-dose
AUCτ,ss
Maximum concentration of drug in plasma at steady state (Cmax,ss)
Time frame: pre-dose (0hour) to 24 hours post-dose
Cmax,ss
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A(AD-236A), Treatment B(AD-236B) and Treatment C(AD-236A+AD-236B) in people with Hyperlipidemia and Diabete Type 2, run by Addpharma Inc. 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 2 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: opening soon, as of the sponsor's last update on 28 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heeyoung Hong (821094710619, hyhong@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss) (time frame: pre-dose (0hour) to 24 hours post-dose). The study lists 2 primary outcomes in all. 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 28 Jul 2026.