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

• Sponsor: Autotelicbio (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05573477
• Collaborator: (none)
• Enrollment: 248
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 18.5
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension; Diabetes Mellitus, Type 2	Drug: ATB-1011; Drug: ATB-1012; Drug: ATB-1013; Drug: ATB-1011 placebo; Drug: ATB-1012 placebo; Drug: ATB-1013 placebo	Phase 3

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

• Study Type: Interventional
• Anticipated Enrollment: 248 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 16, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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-1012 placebo; Placebo matched to ATB-1012; Drug: ATB-1013 placebo; Placebo matched to ATB-1013
Active Comparator: ATB-1012 Participants will receive 1 tablet/day of each drug for 12 weeks	Drug: ATB-1012; Oral tablet; Drug: ATB-1011 placebo; Placebo matched to ATB-1011; Drug: ATB-1013 placebo; Placebo matched to ATB-1013

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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

3. 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

4. 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

5. Changes in MSSBP [baseline to Weeks 4 and 8]

6. Changes in mean sitting diastolic blood pressure (MSDBP) [baseline to Weeks 4, 8, and 12]

7. Changes in HbA1c [baseline to Weeks 4, 8, and 12]

8. Changes in glycemic parameters [baseline to Weeks 4, 8, and 12]

   Fasting plasma glucose (FPG)

9. Changes in glycemic parameters [baseline to Weeks 4, 8, and 12]

   Homeostatic model assessment of beta cell function (HOMA-beta)

10. Changes in glycemic parameters [baseline to Weeks 4, 8, and 12]

    Homeostatic model assessment of insulin resistance (HOMA-IR)

Other Outcome Measures

1. Extension period: Changes in HbA1c [baseline and Week 12 to Weeks 18 and 24]

2. Extension period: Changes in MSSBP [baseline and Week 12 to Weeks 18 and 24]

3. Extension period: Changes in MSDBP [baseline and Week 12 to Weeks 18 and 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	13620

Sponsors and Collaborators

• Autotelicbio

Investigators

• Study Director: James Jun, MD, Autotelicbio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Autotelicbio
• ClinicalTrials.gov Identifier: NCT05573477
• Other Study ID Numbers: ATB-101-003
• First Posted: Oct 10, 2022
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 1, 2023