HypertensionPhase 3NCT07552389
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
A Phase 3 study testing Test group and Exploratory test group in people with Hypertension and Diabete Type 2, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Diabete Type 2
- What is being tested?
- Test group and Exploratory test group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Dec 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea Bucheon St. Mary's Hospital
Seoul
Lim
About this study
Official title: 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
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
- Being tested
- Test group, Exploratory test group, Control group 1, Control group 2
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test groupDrug
HL1113T2 + placebo of HL1113T1, HL1113R1, HL1113R2, once daily, administered for 12 weeks
Exploratory test groupDrug
HL1113T1 + placebo of HL1113T2, HL1113R1, HL1113R2, once daily, administered for 12 weeks
Control group 1Drug
HL1113R1 + placebo of HL1113T1, HL1113T2, HL1113R2, once daily, administered for 12 weeks
Control group 2Drug
HL1113R2 + placebo of HL1113T1, HL1113T2, HL1113R1, once daily, administered for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Drug: Test group |
| Exploratory test group | Experimental | Not described Receives: Drug: Exploratory test group |
| Control group 1 | Placebo comparator | Not described Receives: Drug: Control group 1 |
| Control group 2 | Placebo comparator | Not described Receives: Drug: Control group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2)
Measured: Baseline, 12weeks
Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1)
Measured: Baseline, 12weeks
Secondary outcomes (2)
Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2)
Measured: Baseline, 12weeks
Change from baseline in MSSBP at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1)
Measured: Baseline, 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start18 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552389
- Sponsor's protocol ID
- HL1113-301
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07552389
- Acronym / sponsor ID
- HL1113-301
- Conditions
- Hypertension, Diabete Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test groupHL1113T2 + placebo of HL1113T1, HL1113R1, HL1113R2, once daily, administered for 12 weeks | Drug | Test group |
| Exploratory test groupHL1113T1 + placebo of HL1113T2, HL1113R1, HL1113R2, once daily, administered for 12 weeks | Drug | Exploratory test group |
| Control group 1HL1113R1 + placebo of HL1113T1, HL1113T2, HL1113R2, once daily, administered for 12 weeks | Drug | Control group 1 |
| Control group 2HL1113R2 + placebo of HL1113T1, HL1113T2, HL1113R1, once daily, administered for 12 weeks | Drug | Control group 2 |
Primary outcome
Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2)
Time frame: Baseline, 12weeks
Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1)
Time frame: Baseline, 12weeks
2 secondary outcomes
Change from baseline in HbA1c at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2)
Time frame: Baseline, 12weeks
Change from baseline in MSSBP at Week 12, comparing HL1113T2 with HL1113R1 monotherapy (Test group vs Control group 1)
Time frame: Baseline, 12weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test group and Exploratory test group in people with Hypertension and Diabete Type 2, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang (82234896198, kyliekang@hanlim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 12, comparing HL1113T2 with HL1113R2 monotherapy (Test group vs Control group 2) (time frame: Baseline, 12weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.