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

NCT05573477 | Unknown Phase 3

• 1 other identifier: ATB-101-003
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Essential Hypertension; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

  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

  baseline to Week 12

Secondary Outcomes (10)

• MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)

  baseline to Week 12

• MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)

  baseline to Week 12

• MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012)

  baseline to Week 12

• HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)

  baseline to Week 12

• Changes in MSSBP

  baseline to Weeks 4 and 8

Other Outcomes (3)

• Extension period: Changes in HbA1c

  baseline and Week 12 to Weeks 18 and 24

• Extension period: Changes in MSSBP

  baseline and Week 12 to Weeks 18 and 24

• Extension period: Changes in MSDBP

  baseline and Week 12 to Weeks 18 and 24

Study Arms (4)

ATB-1011 + ATB-1012

EXPERIMENTAL

Participants will receive 1 tablet/day of each drug for 12 weeks

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

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

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

Drug: ATB-1012; Drug: ATB-1011 placebo; Drug: ATB-1013 placebo

Interventions

ATB-1011 DRUG

Oral tablet

ATB-1011; ATB-1011 + ATB-1012

ATB-1012 DRUG

Oral tablet

ATB-1011 + ATB-1012; ATB-1012; ATB-1012 + ATB-1013

ATB-1013 DRUG

Oral tablet

ATB-1012 + ATB-1013

ATB-1011 placebo DRUG

Placebo matched to ATB-1011

ATB-1012; ATB-1012 + ATB-1013

ATB-1012 placebo DRUG

Placebo matched to ATB-1012

ATB-1011

ATB-1013 placebo DRUG

Placebo matched to ATB-1013

ATB-1011; ATB-1011 + ATB-1012; ATB-1012

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Autotelicbio: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• James Jun, MD

  Autotelicbio

  STUDY DIRECTOR

Central Study Contacts

Jaymin Jeong, PhD

CONTACT

+82-70-4242-5334; jaymin.jeong@autotelic.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: November 16, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)