Evaluation of Efficacy and Safety of ATB-1011+ATB-1012 Co-administration for Essential Hypertension and Type II Diabetes

August 25, 2026 updated by: Autotelicbio

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
255

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ATB-1011 + ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
Drug: ATB-1011
Oral tablet
Drug: ATB-1012
Oral tablet
Drug: ATB-1013 placebo
Placebo matched to ATB-1013
Experimental: ATB-1012 + ATB-1013
Participants will receive 1 tablet/day of each drug for 12 weeks
Drug: ATB-1012
Oral tablet
Drug: ATB-1013
Oral tablet
Drug: ATB-1011 placebo
Placebo matched to ATB-1011
Active Comparator: ATB-1011
Participants will receive 1 tablet/day of each drug for 12 weeks
Drug: ATB-1011
Oral tablet
Drug: ATB-1013 placebo
Placebo matched to ATB-1013
Drug: ATB-1012 placebo
Placebo matched to ATB-1012
Active Comparator: ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
Drug: ATB-1012
Oral tablet
Drug: ATB-1013 placebo
Placebo matched to ATB-1013
Drug: ATB-1011 placebo
Placebo matched to ATB-1011

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline to Week 12
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
baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)
Time Frame: baseline to Week 12
Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
baseline to Week 12
MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)
Time Frame: baseline to Week 12
Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1012 monotherapy
baseline to Week 12
MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012)
Time Frame: baseline to Week 12
Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1011 + ATB-1012 co-administration
baseline to Week 12
HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)
Time Frame: baseline to Week 12
Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
baseline to Week 12
Changes in MSSBP
Time Frame: baseline to Weeks 4 and 8
baseline to Weeks 4 and 8
Changes in mean sitting diastolic blood pressure (MSDBP)
Time Frame: baseline to Weeks 4, 8, and 12
baseline to Weeks 4, 8, and 12
Changes in HbA1c
Time Frame: baseline to Weeks 4, 8, and 12
baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Time Frame: baseline to Weeks 4, 8, and 12
Fasting plasma glucose (FPG)
baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Time Frame: baseline to Weeks 4, 8, and 12
Homeostatic model assessment of beta cell function (HOMA-beta)
baseline to Weeks 4, 8, and 12
Changes in glycemic parameters
Time Frame: baseline to Weeks 4, 8, and 12
Homeostatic model assessment of insulin resistance (HOMA-IR)
baseline to Weeks 4, 8, and 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Extension period: Changes in HbA1c
Time Frame: baseline and Week 12 to Weeks 18 and 24
baseline and Week 12 to Weeks 18 and 24
Extension period: Changes in MSSBP
Time Frame: baseline and Week 12 to Weeks 18 and 24
baseline and Week 12 to Weeks 18 and 24
Extension period: Changes in MSDBP
Time Frame: baseline and Week 12 to Weeks 18 and 24
baseline and Week 12 to Weeks 18 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Autotelicbio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: James Jun, MD, Autotelicbio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATB-101-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings