Type 2 Diabetes Mellitus (T2DM)Phase 3NCT07816198
A Study to Evaluate the Efficacy and Safety of AD-233A, AD-233B, AD-233C and/or AD-233D Combination Therapy
A Phase 3 study testing AD-233A, AD-233B and AD-233C in people with Type 2 Diabetes Mellitus (T2DM), run by Addpharma Inc..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of AD-233A, AD-233B, AD-233C and/or AD-233D combination therapy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- AD-233A, AD-233B and AD-233C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Jun 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Other inclusions applied
Who cannot join
- Subjects with severe diabetic complications
- Other exclusions applied
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Seong rae Kim, Principal Investigator contact
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of AD-233A, AD-233B, AD-233C and/or AD-233D Combination Therapy in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the efficacy and safety of AD-233A, AD-233B, AD-233C and/or AD-233D combination therapy
Read the detailed description
Condition or disease: Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- AD-233A, AD-233B, AD-233C, AD-233D, AD-233A Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-233ADrug
PO, Once daily(QD), 24 weeks
AD-233BDrug
PO, Once daily(QD), 24 weeks
AD-233CDrug
PO, Once daily(QD), 24 weeks
AD-233DDrug
PO, Once daily(QD), 24 weeks
AD-233A PlaceboDrug
PO, Once daily(QD), 24 weeks
AD-233B PlaceboDrug
PO, Once daily(QD), 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | AD-233A+AD-233B+AD-233C and/or AD-233D Receives: Drug: AD-233A; Drug: AD-233B; Drug: AD-233C; Drug: AD-233D |
| Control Group 1 | Active comparator | AD-233A Placebo+AD-233B+AD-233C and/or AD-233D Receives: Drug: AD-233B; Drug: AD-233C; Drug: AD-233D; Drug: AD-233A Placebo |
| Control Group 2 | Active comparator | AD-233A+AD-233B Placebo+AD-233C and/or AD-233D Receives: Drug: AD-233A; Drug: AD-233C; Drug: AD-233D; Drug: AD-233B Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c(Hemoglobin a1c) from baseline at Week 24 after administration of IP(Investigator's Product)
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 354 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
- NCT07816198
- Sponsor's protocol ID
- AD-233P3
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of AD-233A, AD-233B, AD-233C and/or AD-233D Combination Therapy in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07816198
- Acronym / sponsor ID
- AD-233P3
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Sep 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.
The purpose of this study is to evaluate the efficacy and safety of AD-233A, AD-233B, AD-233C and/or AD-233D combination therapy
Detailed description
Condition or disease: Type 2 Diabetes Mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: AD-233A, Drug: AD-233B, Drug: AD-233C, Drug: AD-233DAD-233A+AD-233B+AD-233C and/or AD-233D |
| Control Group 1 | Active comparator | Drug: AD-233B, Drug: AD-233C, Drug: AD-233D, Drug: AD-233A PlaceboAD-233A Placebo+AD-233B+AD-233C and/or AD-233D |
| Control Group 2 | Active comparator | Drug: AD-233A, Drug: AD-233C, Drug: AD-233D, Drug: AD-233B PlaceboAD-233A+AD-233B Placebo+AD-233C and/or AD-233D |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Other inclusions applied
Key exclusion criteria (2 listed)
- Subjects with severe diabetic complications
- 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 |
|---|---|---|
| AD-233APO, Once daily(QD), 24 weeks | Drug | Control Group 2, Test Group |
| AD-233BPO, Once daily(QD), 24 weeks | Drug | Control Group 1, Test Group |
| AD-233CPO, Once daily(QD), 24 weeks | Drug | Control Group 1, Control Group 2, Test Group |
| AD-233DPO, Once daily(QD), 24 weeks | Drug | Control Group 1, Control Group 2, Test Group |
| AD-233A PlaceboPO, Once daily(QD), 24 weeks | Drug | Control Group 1 |
| AD-233B PlaceboPO, Once daily(QD), 24 weeks | Drug | Control Group 2 |
Primary outcome
Change in HbA1c(Hemoglobin a1c) from baseline at Week 24 after administration of IP(Investigator's Product)
Time frame: Baseline, Week 24
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 16 Sep 2026.
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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.
Seong rae Kim, Principal Investigator contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AD-233A, AD-233B and AD-233C in people with Type 2 Diabetes Mellitus (T2DM), run by Addpharma Inc..
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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Hanna Yang (82+01084267236, hnyang@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c(Hemoglobin a1c) from baseline at Week 24 after administration of IP(Investigator's Product) (time frame: Baseline, Week 24). 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 16 Sep 2026.