ObesePhase 2NCT07205900
Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus
A Phase 2 study testing HM15275 in people with Obese and Obesity, run by Hanmi Pharmaceutical Company Limited at 14 sites in United States.
Trial summary
This Study is a Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Obese or Overweight Subjects Without Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 267 participants
- Where
- 14 sitesUnited States
- Study dates
- 2 Dec 2025to Jan 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)
- Korea: 19 to 75 years (inclusive)
- BMI ≥30 kg/m² and ≤50 kg/m², or ≥27 kg/m² and <30 kg/m² with ≥1 weight-related comorbidity
- Body weight change <5% over the past 3 months prior to screening
- Capable of giving signed informed consent, ability and willingness to comply with all protocol procedures
Who cannot join
- Type 1 diabetes mellitus or T2DM, or HbA1c ≥6.5% / FPG ≥126 mg/dL
- Obesity due to endocrine/genetic disorders
- Planned or prior obesity surgery (unless >1 year ago for liposuction/abdominoplasty), or device-based obesity therapy (unless removed >6 months ago)
- Personal history or current diagnosis of acute or chronic pancreatitis or factors that may increase the risk of pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse.
- Personal or family history of medullary thyroid carcinoma (MTC) or a known genetic condition (e.g., multiple endocrine neoplasia type 2) that predisposes the participant to MTC.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- History or current diagnosis of congestive heart failure (NYHA class Ⅲ or Ⅳ), or myocardial infarction, stroke, unstable angina, transient ischemic attack, or revascularization procedure (e.g., stent or bypass graft surgery) within 3 months prior to screening visit
- Personal history or current diagnosis of acute or chronic pancreatitis or factors that may increase the risk of pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Accellacare of McFarland
Ames, Iowa, 50010
Texas Clinical Research Institute
Arlington, Texas, 76012
Accellacare of Bristol-PAC of Tennessee
Bristol, Tennessee, 37620
Bristol-Internal Medicine and Pediatric Associates of Bristol, P.C.
Bristol, Tennessee, 37620
Accellacare of Cary - Cary Medical Group
Cary, North Carolina, 27511
ProSciento Inc
Chula Vista, California, 91911
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Accellacare of Hickory
Hickory, North Carolina, 28601
Accellacare of Charleston
Mt. Pleasant, South Carolina, 29464
Accellacare of Duly - Duly Oak Lawn
Oak Lawn, Illinois, 60453
Raleigh Medical Group, P.A.
Raleigh, North Carolina, 27609
Accellacare of Piedmont - Piedmont HealthCare
Statesville, North Carolina, 28626
Accellacare of Wilmington, LLC
Wilmington, North Carolina, 28401
Accellacare of Winston Salem
Winston-Salem, North Carolina, 27103
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 Obese or Overweight Subjects Without Diabetes Mellitus
This Study is a Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Obese or Overweight Subjects Without Diabetes Mellitus.
Read the detailed description
HM-OBCT-201 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 obese or overweight adults without Type 2 diabetes mellitus (T2DM).
The study will enroll adult participants with obesity (body mass index [BMI] ≥30 kg/m2 and ≤50 kg/m2) or with overweight (BMI ≥27 kg/m2 and <30 kg/m2) with at least 1 weight-related comorbidity. Patients with T2DM will be excluded.
Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms. Randomization will be stratified by sex (female vs male) and BMI (<35 vs ≥35 kg/m2).
All participants will undergo a 6-week screening period, a 36-week treatment period (including the dose-titration phase with weekly subcutaneous [SC] injection), and a 4-week safety follow-up period.
- Being tested
- HM15275, Placebo of HM15275
- Keywords
- Obese, Obesity
- Medical subject headings
- Obesity
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.
Percent Change in Body Weight.
Percent change in body weight from Week 1 to Week 37, measured using a standardized, calibrated scale under fasting conditions.
Measured: Up to 41 weeks
Secondary outcomes (1)
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 posted3 Oct 2025
- Study start2 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Model description
- Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
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
- NCT07205900
- Sponsor's protocol ID
- HM-OBCT-201
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 8 Apr 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 8 Apr 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 Obese or Overweight Subjects Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07205900
- Acronym / sponsor ID
- HM-OBCT-201
- Keywords
- Obese, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Oct 2025 (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 Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Obese or Overweight Subjects Without Diabetes Mellitus.
Detailed description
HM-OBCT-201 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 obese or overweight adults without Type 2 diabetes mellitus (T2DM).
The study will enroll adult participants with obesity (body mass index [BMI] ≥30 kg/m2 and ≤50 kg/m2) or with overweight (BMI ≥27 kg/m2 and <30 kg/m2) with at least 1 weight-related comorbidity. Patients with T2DM will be excluded.
Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms. Randomization will be stratified by sex (female vs male) and BMI (<35 vs ≥35 kg/m2).
All participants will undergo a 6-week screening period, a 36-week treatment period (including the dose-titration phase with weekly subcutaneous [SC] injection), 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
- Model description
- Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms.
| 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 (6 listed)
- Participant's age at the time of signing the informed consent:
- BMI ≥30 kg/m² and ≤50 kg/m², or ≥27 kg/m² and <30 kg/m² with ≥1 weight-related comorbidity
- Body weight change <5% over the past 3 months prior to screening
- Capable of giving signed informed consent, ability and willingness to comply with all protocol procedures
Key exclusion criteria (8 listed)
- Type 1 diabetes mellitus or T2DM, or HbA1c ≥6.5% / FPG ≥126 mg/dL
- Obesity due to endocrine/genetic disorders
- Planned or prior obesity surgery (unless >1 year ago for liposuction/abdominoplasty), or device-based obesity therapy (unless removed >6 months ago)
- Personal history or current diagnosis of acute or chronic pancreatitis or factors that may increase the risk of pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse.
- Personal or family history of medullary thyroid carcinoma (MTC) or a known genetic condition (e.g., multiple endocrine neoplasia type 2) that predisposes the participant to MTC.
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
Percent Change in Body Weight.
Time frame: Up to 41 weeks
Percent change in body weight from Week 1 to Week 37, measured using a standardized, calibrated scale under fasting conditions.
1 secondary outcome
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 8 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 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 Obese and Obesity, run by Hanmi Pharmaceutical Company Limited at 14 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 6 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: under way, not looking for participants, as of the sponsor's last update on 8 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 14 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight. (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 8 Apr 2026.