Type 2 Diabetes MellitusPhase 2NCT07527650
Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing HM15275 in people with Type 2 Diabetes Mellitus and T2DM, run by Hanmi Pharmaceutical Company Limited at 20 sites in United States.
Trial summary
This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, T2DM
- What is being tested?
- HM15275
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 20 sitesUnited States
- Study dates
- 18 May 2026to Oct 2027
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant's age at the time of signing the informed consent:
- United States: 18 to 75 years (inclusive)
- Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
- Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
- BMI ≥25 kg/m² and ≤50 kg/m²
- Body weight change <5% over the past 3 months prior to screening
- Capable of giving signed informed consent and willing to comply with all protocol procedures
Who cannot join
- Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
- Poor glycemic control (fasting plasma glucose >270 mg/dL)
- History of diabetic ketoacidosis or severe hypoglycemia within 6 months
- Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
- History of pancreatitis or factors increasing the risk of pancreatitis
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
- Clinically significant liver disease, renal impairment (eGFR <60 mL/min/1.73 m²), or abnormal laboratory findings at screening
- Participation in another investigational study within 30 days or within 5 half-lives of the investigational product, whichever is longer; for GLP-1 receptor agonist-related or weight loss studies, participation within 3 months prior to screening
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Charter Research - Chicago
Chicago, Illinois, 60618
Tiffany Nguyen
- Recruiting
Centricity Research IRT - DBA IACT Health Columbus Piedmont
Columbus, Georgia, 31904
Steven Leichter
- Recruiting
Centricity Research Columbus
Columbus, Ohio, 43213
Sridhar Guduri
- Recruiting
Accel Research Sites - DeLand
DeLand, Florida, 32720
Bruce Rankin
- Recruiting
Methodist Physicians Clinic
Fremont, Nebraska, 68025
Thomas Wolf
- Recruiting
Jefferson City Medical Center
Jefferson City, Missouri, 65109
Benjamin Cook
- Recruiting
Clay Platte Family Medicine
Kansas City, Missouri, 64151
Scott Kuennen
- Recruiting
Santa Rosa Medical Centers of Nevada
Las Vegas, Nevada, 89119
Syed Pervaiz
- Recruiting
Manassas Clinical Research Center
Manassas, Virginia, 20110
Nabil Saleh Andrawis
- Recruiting
Desert Clinical Research
Mesa, Arizona, 85123
Gerald Shockey
- Recruiting
Lucas Research, Inc.
Morehead City, North Carolina, 28557
Kathryn Jean Lucas
- Recruiting
Charter Research
Orlando, Florida, 32803
Mary Hilal Quarterman
- Recruiting
AdventHealth Translational Research Institute
Orlando, Florida, 32804
Richard Edwin Pratley
- Recruiting
Olympus Family Medicine
Salt Lake City, Utah, 84117
Jared Probst
- Recruiting
Highland Clinical Research
Salt Lake City, Utah, 84124
Derek Muse
- Recruiting
Care Access Research - Santa Clarita
Santa Clarita, California, 91321
Sina Tebi
- Recruiting
The South Bend Clinic
South Bend, Indiana, 46617
Rita Schmid
- Recruiting
K2 Medical Research The Villages LLC
The Villages, Florida, 32159
Craig T Curtis
- Recruiting
Charter Research - The Villages
The Villages, Florida, 32162
Stephen Mark Miller
- Recruiting
DM Clinical Research
Tomball, Texas, 77375
Muhammad Irfan
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Subjects With Type 2 Diabetes Mellitus
This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.
Read the detailed description
HM-OBCT-202 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group study designed to evaluate the efficacy, safety, and tolerability of HM15275 treatment over 36 weeks in adults with type 2 diabetes mellitus (T2DM).
The study will enroll adult participants with T2DM (aged 18 to 75 years) who have inadequate glycemic control. Eligible participants must have a body mass index (BMI) ≥25 kg/m² and ≤50 kg/m² and HbA1c between 7.0% and 10.0% at screening.
Participants in this study will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms. Randomization will be stratified by screening HbA1c (≤8.0% versus >8.0%) and use of metformin (yes versus no).
All participants will undergo a 4-week screening period, a 36-week treatment period (including weekly subcutaneous [SC] injection of study drug), and a 4-week safety follow-up period.
- Conditions
- Type 2 Diabetes Mellitus, T2DM
- Being tested
- HM15275, Placebo of HM15275
- Keywords
- Type 2 Diabetes Mellitus, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM15275Drug
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
Placebo of HM15275Drug
A sterile, matching solution supplied in pre-filled syringes.
| Study group | Role | What they receive |
|---|---|---|
| HM15275 | Experimental | Participants will receive HM15275 via subcutaneous (SC) injection. Receives: Drug: HM15275 |
| Placebo of HM15275 | Placebo comparator | Participants will receive placebo of HM15275 via subcutaneous (SC) injection. Receives: Drug: Placebo of HM15275 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c)
Change in HbA1c (%) from randomization to Week 37.
Measured: Up to 41 weeks
Secondary outcomes (2)
Percentage of participants reaching specified HbA1c (%)
Percentage of participants reaching specified high, medium, and low HbA1c (%) after multiple subcutaneous (SC) doses.
Measured: Up to 41 weeks
Number of participants with adverse events (AEs)
Number of participants with adverse events (AEs) after multiple subcutaneous (SC) doses.
Measured: Up to 41 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start18 May 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527650
- Sponsor's protocol ID
- HM-OBCT-202
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07527650
- Acronym / sponsor ID
- HM-OBCT-202
- Conditions
- Type 2 Diabetes Mellitus, T2DM
- Keywords
- Type 2 Diabetes Mellitus, T2DM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 14 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 study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.
Detailed description
HM-OBCT-202 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group study designed to evaluate the efficacy, safety, and tolerability of HM15275 treatment over 36 weeks in adults with type 2 diabetes mellitus (T2DM).
The study will enroll adult participants with T2DM (aged 18 to 75 years) who have inadequate glycemic control. Eligible participants must have a body mass index (BMI) ≥25 kg/m² and ≤50 kg/m² and HbA1c between 7.0% and 10.0% at screening.
Participants in this study will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms. Randomization will be stratified by screening HbA1c (≤8.0% versus >8.0%) and use of metformin (yes versus no).
All participants will undergo a 4-week screening period, a 36-week treatment period (including weekly subcutaneous [SC] injection of study drug), and a 4-week safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HM15275 | Experimental | Drug: HM15275Participants will receive HM15275 via subcutaneous (SC) injection. |
| Placebo of HM15275 | Placebo comparator | Drug: Placebo of HM15275Participants will receive placebo of HM15275 via subcutaneous (SC) injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant's age at the time of signing the informed consent:
- Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
- Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
- BMI ≥25 kg/m² and ≤50 kg/m²
- Body weight change <5% over the past 3 months prior to screening
Key exclusion criteria (8 listed)
- Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
- Poor glycemic control (fasting plasma glucose >270 mg/dL)
- History of diabetic ketoacidosis or severe hypoglycemia within 6 months
- Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
- History of pancreatitis or factors increasing the risk of pancreatitis
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 |
|---|---|---|
| HM15275HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes. | Drug | HM15275 |
| Placebo of HM15275A sterile, matching solution supplied in pre-filled syringes. | Drug | Placebo of HM15275 |
Primary outcome
Change in Glycated Hemoglobin (HbA1c)
Time frame: Up to 41 weeks
Change in HbA1c (%) from randomization to Week 37.
2 secondary outcomes
Percentage of participants reaching specified HbA1c (%)
Time frame: Up to 41 weeks
Number of participants with adverse events (AEs)
Time frame: Up to 41 weeks
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 19 Oct 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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HM15275 in people with Type 2 Diabetes Mellitus and T2DM, run by Hanmi Pharmaceutical Company Limited at 20 sites in United States.
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 7 inclusion and 8 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Pureun Nam (+82-2-410-9147, pureun.nam@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) (time frame: Up to 41 weeks). 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 19 Oct 2026.