Essential HypertensionPhase 3NCT05573477
Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes
A Phase 3 study testing ATB-1011, ATB-1012 and ATB-1013 in people with Essential Hypertension and Diabetes Mellitus, Type 2, run by Autotelicbio at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and efficacy of ATB-1011 and ATB-1012 co-administration in patients with essential hypertension and type II diabetes mellitus Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension, Diabetes Mellitus, Type 2
- What is being tested?
- ATB-1011, ATB-1012 and ATB-1013
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2022to 28 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those with Primary Hypertension and Type II Diabetes Mellitus (DM)
- Those who have been given adequate explanation about the purpose and the details of the clinical trial and have given voluntary, written informed consent
- Those who have not taken any antihypertensive agents for ≥2 weeks prior to randomization.
- Those who have not taken any oral hypoglycemic agents, except for same dose of metformin (≥1000 mg/day), for ≥8 weeks prior to randomization
Who cannot join
- Those with reference arm mean sitting diastolic blood pressure (MSDBP) ≥110 mmHg at screening or at randomization
- Those with differences of systolic blood pressure (SBP) ≥ 20 mmHg and diastolic blood pressure (DBP) ≥ 10 mmHg between arms measured 3 consecutive times with ≥2 minutes between each measurement at screening
- Those with a history of alcohol or substance abuse
- Those who are pregnant or nursing
- Those who have received other clinical trial drugs within 12 weeks prior to screening
- Those who are deemed ineligible to participate in the clinical trial based on the medical opinion of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: A Randomized, Active-controlled, Double-blind, Parallel, Multi Center, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated ATB-1011 and ATB-1012 in Patients With Essential Hypertension and Type II Diabetes Mellitus
The purpose of this study is to evaluate safety and efficacy of ATB-1011 and ATB-1012 co-administration in patients with essential hypertension and type II diabetes mellitus
Read the detailed description
Primary Objectives:
- To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in blood pressure control over ATB-1012 monotherapy
- To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in diabetes control over ATB-1011 monotherapy
- Conditions
- Essential Hypertension, Diabetes Mellitus, Type 2
- Being tested
- ATB-1011, ATB-1012, ATB-1013, ATB-1011 placebo, ATB-1012 placebo
- Medical subject headings
- Essential Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATB-1011Drug
Oral tablet
ATB-1012Drug
Oral tablet
ATB-1013Drug
Oral tablet
ATB-1011 placeboDrug
Placebo matched to ATB-1011
ATB-1012 placeboDrug
Placebo matched to ATB-1012
ATB-1013 placeboDrug
Placebo matched to ATB-1013
| Study group | Role | What they receive |
|---|---|---|
| ATB-1011 + ATB-1012 | Experimental | Participants will receive 1 tablet/day of each drug for 12 weeks Receives: Drug: ATB-1011; Drug: ATB-1012; Drug: ATB-1013 placebo |
| ATB-1012 + ATB-1013 | Experimental | Participants will receive 1 tablet/day of each drug for 12 weeks Receives: Drug: ATB-1012; Drug: ATB-1013; Drug: ATB-1011 placebo |
| ATB-1011 | Active comparator | Participants will receive 1 tablet/day of each drug for 12 weeks Receives: Drug: ATB-1011; Drug: ATB-1012 placebo; Drug: ATB-1013 placebo |
| ATB-1012 | Active comparator | Participants will receive 1 tablet/day of each drug for 12 weeks Receives: Drug: ATB-1012; Drug: ATB-1011 placebo; Drug: ATB-1013 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012)
Change in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
Measured: baseline to Week 12
Hemoglobin A1c (HbA1c) (ATB-1011+ATB-1012 vs. ATB-1011)
Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
Measured: baseline to Week 12
Secondary outcomes (10)
MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)
Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
Measured: baseline to Week 12
MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)
Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1012 monotherapy
Measured: baseline to Week 12
MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012)
Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1011 + ATB-1012 co-administration
Measured: baseline to Week 12
HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)
Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
Measured: baseline to Week 12
Changes in MSSBP
Measured: baseline to Weeks 4 and 8
Changes in mean sitting diastolic blood pressure (MSDBP)
Measured: baseline to Weeks 4, 8, and 12
Changes in HbA1c
Measured: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Fasting plasma glucose (FPG)
Measured: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Homeostatic model assessment of beta cell function (HOMA-beta)
Measured: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Homeostatic model assessment of insulin resistance (HOMA-IR)
Measured: baseline to Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start16 Nov 2022
- Primary completion31 Aug 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies 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
- Model description
- Participants will be randomized in a 1:1:1:1 ratio to 4 treatment arms. After completion of treatment period, participants will enter 12-week extension period and take 1 tab/day of ATB-1011 and ATB-1012.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autotelicbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Jun, MD, Study director, Autotelicbio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573477
- Sponsor's protocol ID
- ATB-101-003
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2022
- Last updated
- 27 Aug 2026
- Results posted
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active-controlled, Double-blind, Parallel, Multi Center, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated ATB-1011 and ATB-1012 in Patients With Essential Hypertension and Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05573477
- Acronym / sponsor ID
- ATB-101-003
- Conditions
- Essential Hypertension, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- AutotelicbioIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 10 Oct 2022 (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 safety and efficacy of ATB-1011 and ATB-1012 co-administration in patients with essential hypertension and type II diabetes mellitus
Detailed description
Primary Objectives:
- To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in blood pressure control over ATB-1012 monotherapy
- To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in diabetes control over ATB-1011 monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants will be randomized in a 1:1:1:1 ratio to 4 treatment arms. After completion of treatment period, participants will enter 12-week extension period and take 1 tab/day of ATB-1011 and ATB-1012.
| Arm | Type | Receives |
|---|---|---|
| ATB-1011 + ATB-1012 | Experimental | Drug: ATB-1011, Drug: ATB-1012, Drug: ATB-1013 placeboParticipants will receive 1 tablet/day of each drug for 12 weeks |
| ATB-1012 + ATB-1013 | Experimental | Drug: ATB-1012, Drug: ATB-1013, Drug: ATB-1011 placeboParticipants will receive 1 tablet/day of each drug for 12 weeks |
| ATB-1011 | Active comparator | Drug: ATB-1011, Drug: ATB-1012 placebo, Drug: ATB-1013 placeboParticipants will receive 1 tablet/day of each drug for 12 weeks |
| ATB-1012 | Active comparator | Drug: ATB-1012, Drug: ATB-1011 placebo, Drug: ATB-1013 placeboParticipants will receive 1 tablet/day of each drug for 12 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those with Primary Hypertension and Type II Diabetes Mellitus (DM)
- Those who have been given adequate explanation about the purpose and the details of the clinical trial and have given voluntary, written informed consent
- Those who have not taken any antihypertensive agents for ≥2 weeks prior to randomization.
- Those who have not taken any oral hypoglycemic agents, except for same dose of metformin (≥1000 mg/day), for ≥8 weeks prior to randomization
Key exclusion criteria (6 listed)
- Those with reference arm mean sitting diastolic blood pressure (MSDBP) ≥110 mmHg at screening or at randomization
- Those with differences of systolic blood pressure (SBP) ≥ 20 mmHg and diastolic blood pressure (DBP) ≥ 10 mmHg between arms measured 3 consecutive times with ≥2 minutes between each measurement at screening
- Those with a history of alcohol or substance abuse
- Those who are pregnant or nursing
- Those who have received other clinical trial drugs within 12 weeks prior to screening
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 |
|---|---|---|
| ATB-1011Oral tablet | Drug | ATB-1011, ATB-1011 + ATB-1012 |
| ATB-1012Oral tablet | Drug | ATB-1011 + ATB-1012, ATB-1012, ATB-1012 + ATB-1013 |
| ATB-1013Oral tablet | Drug | ATB-1012 + ATB-1013 |
| ATB-1011 placeboPlacebo matched to ATB-1011 | Drug | ATB-1012, ATB-1012 + ATB-1013 |
| ATB-1012 placeboPlacebo matched to ATB-1012 | Drug | ATB-1011 |
| ATB-1013 placeboPlacebo matched to ATB-1013 | Drug | ATB-1011, ATB-1011 + ATB-1012, ATB-1012 |
Primary outcome
Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012)
Time frame: baseline to Week 12
Change in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
Hemoglobin A1c (HbA1c) (ATB-1011+ATB-1012 vs. ATB-1011)
Time frame: baseline to Week 12
Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
10 secondary outcomes
MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)
Time frame: baseline to Week 12
MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)
Time frame: baseline to Week 12
MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012)
Time frame: baseline to Week 12
HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)
Time frame: baseline to Week 12
Changes in MSSBP
Time frame: baseline to Weeks 4 and 8
Changes in mean sitting diastolic blood pressure (MSDBP)
Time frame: baseline to Weeks 4, 8, and 12
Changes in HbA1c
Time frame: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Time frame: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Time frame: baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Time frame: baseline to Weeks 4, 8, and 12
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 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
James Jun, MD study director
Autotelicbio
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 ATB-1011, ATB-1012 and ATB-1013 in people with Essential Hypertension and Diabetes Mellitus, Type 2, run by Autotelicbio 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 4 inclusion and 6 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 27 Aug 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?
Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012) (time frame: baseline to Week 12). 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 27 Aug 2026.