Clinical Trial to Evaluate the Efficacy and Safety of Monotherapy Group of HL1113R1 or HL1113R2 Versus HL1113 (Fixed Dose Combination) in Patients With Essential Hypertension and Type II Diabetes Mellitus

NCT07552389 | Recruiting Phase 3

• 1 other identifier: HL1113-301
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a randomized, active controlled, double blind, parallel, multi center, phase 3 study to evaluate the efficacy and safety of monotherapy group of HL1113R1 or HL1113R2 versus HL1113 (Fixed dose combination) in patients with essential hypertension and type II diabetes mellitus

Conditions

Hypertension; Diabete Type 2

Outcome Measures

Primary Outcomes (2)

• Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2)

  Baseline, 12weeks

• Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1)

  Baseline, 12weeks

Secondary Outcomes (2)

• Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2)

  Baseline, 12weeks

• Change from baseline in MSSBP at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1)

  Baseline, 12weeks

Study Arms (4)

Test group

EXPERIMENTAL

Drug: Test group

Exploratory test group

EXPERIMENTAL

Drug: Exploratory test group

Control group 1

PLACEBO COMPARATOR

Drug: Control group 1

Control group 2

PLACEBO COMPARATOR

Drug: Control group 2

Interventions

Test group DRUG

HL1113T2 + placebo of HL1113T1, HL1113R1, HL1113R2, once daily, administered for 12 weeks

Test group

Exploratory test group DRUG

HL1113T1 + placebo of HL1113T2, HL1113R1, HL1113R2, once daily, administered for 12 weeks

Exploratory test group

Control group 1 DRUG

HL1113R1 + placebo of HL1113T1, HL1113T2, HL1113R2, once daily, administered for 12 weeks

Control group 1

Control group 2 DRUG

HL1113R2 + placebo of HL1113T1, HL1113T2, HL1113R1, once daily, administered for 12 weeks

Control group 2

Eligibility Criteria

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

You may qualify if:

• Adult male or female subjects aged ≥19 years at the time of written informed consent.
• Subjects diagnosed with essential hypertension accompanied by type 2 diabetes mellitus.
• etc.

You may not qualify if:

• Subjects whose blood pressure measured in the selected arm at both screening and randomization meets the following criterion: MSDBP ≥ 110 mmHg
• Subjects whose blood pressure measured three consecutive times in each arm at intervals of at least 2 minutes at screening shows a difference of ≥20 mmHg in SBP and ≥10 mmHg in DBP.
• etc.

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

The Catholic University of Korea Bucheon St. Mary's Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kang

CONTACT

82234896198; kyliekang@hanlim.com

Study Design

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

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 27, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)