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

Phase 3

Recruiting

• Conditions: Essential Hypertension; Diabetes Mellitus, Type 2
• Interventions: Drug: ATB-1012; Drug: ATB-1011; Drug: ATB-1012 placebo; Drug: ATB-1013; Drug: ATB-1013 placebo; Drug: ATB-1011 placebo

• Registration Number: NCT05573477
• Lead Sponsor: Autotelicbio

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

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 Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Study Start: 2022-11-16
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATB-1012 + ATB-1013	ATB-1012	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1011	ATB-1012 placebo	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1011	ATB-1013 placebo	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1011 + ATB-1012	ATB-1012	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1012 + ATB-1013	ATB-1013	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1011	ATB-1011	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1011 + ATB-1012	ATB-1013 placebo	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1012 + ATB-1013	ATB-1011 placebo	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1012	ATB-1012	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1012	ATB-1013 placebo	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1012	ATB-1011 placebo	Participants will receive 1 tablet/day of each drug for 12 weeks
ATB-1011 + ATB-1012	ATB-1011	Participants will receive 1 tablet/day of each drug for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012)	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)	baseline to Week 12	Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy

Secondary Outcome Measures

Name	Time	Method
HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)	baseline to Week 12	Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)	baseline to Week 12	Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1012 monotherapy
MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012)	baseline to Week 12	Changes in MSSBP with ATB-1012 + ATB-1013 co-administration compared to ATB-1011 + ATB-1012 co-administration
Changes in MSSBP	baseline to Weeks 4 and 8
MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)	baseline to Week 12	Changes in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
Changes in mean sitting diastolic blood pressure (MSDBP)	baseline to Weeks 4, 8, and 12
Changes in HbA1c	baseline to Weeks 4, 8, and 12
Changes in glycemic parameters	baseline to Weeks 4, 8, and 12	Homeostatic model assessment of insulin resistance (HOMA-IR)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of