ObesityPhase 1NCT06481098
A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects.
A Phase 1 study testing HM15275 in people with Obesity, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- 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
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 2 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female and male adults, ages ≥ 18 and ≤ 65 years.
- Part A: Healthy subjects with body mass index (BMI) ≥ 20.0 kg/m2 and ≤ 27 kg/m2.
- Part B: Obese subjects with BMI ≥ 30.0 kg/m2 and ≤ 45.0 kg/m2 with a stable body weight for 3 months prior to screening (defined as change < 5%).
- HbA1c < 6.5 % [based on American Diabetes Association, 2023].
- Female subjects must be non-pregnant and non-lactating.
- Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.
Who cannot join
- Subject with existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product.
- Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for < 5 years.
- Subjects with a history of any serious adverse reaction or hypersensitivity to study drug components (includes GLP-1, GIP, glucagon analogs) or have contraindicating diseases.
- Subjects with confirmed type 1 or type 2 diabetes.
- Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within from 24 hours before each study visit and while subjects are confined to the study center.
- Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the Follow-up visit.
- History of alcohol abuse as judged by the Investigator within approximately 1 year prior to Screening.
- History of regular use (defined as ≥ 10 cigarettes per day) of nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipe, chewing tobacco, nicotine patch or gum) or vaping products within 6 weeks prior to check-in for the first In-house Period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects
This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.
- Conditions
- Obesity
- Being tested
- HM15275, Placebo of HM15275
- Keywords
- 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 | Active comparator:
Part A: single-ascending dose
Single doses of HM15275 in healthy adults administered via subcutaneous injection.
Part B: multiple-ascending dose
Multiple doses of HM15275 in obese adults administered via subcutaneous injection. Receives: Drug: HM15275; Drug: Placebo of HM15275 |
| Placebo of HM15275 | Placebo comparator | Placebo comparator:
Part A: single-ascending dose
Single doses of HM15275 placebo in healthy adults administered via subcutaneous injection.
Part B: multiple-ascending dose
Multiple doses of HM15275 placebo in obese adults administered via subcutaneous injection. Receives: Drug: HM15275; Drug: Placebo of HM15275 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety and Tolerability
Number of participants with treatment-emergent adverse events (TEAEs) after a single subcutaneous dose
Measured: Up to Day 29
Part B: Safety and Tolerability
Number of participants with treatment-emergent adverse events (TEAEs) after multiple subcutaneous doses
Measured: Up to Day 57
Secondary outcomes (2)
Part A: Pharmacokinetics
Plasma concentration profile of HM15275 over time after a single subcutaneous dose
Measured: Up to Day 29
Part B: Pharmacokinetics
Plasma concentration profile of HM15275 over time after multiple subcutaneous doses
Measured: Up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start28 May 2024
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A: single-ascending dose Part B: multiple-ascending dose
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 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
- NCT06481098
- Sponsor's protocol ID
- HM-OBCT-101
- Status last verified
- May 2025
- First submitted
- 30 May 2024
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects
- ClinicalTrials.gov ID
- NCT06481098
- Acronym / sponsor ID
- HM-OBCT-101
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 1 Jul 2024 (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 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Part A: single-ascending dose Part B: multiple-ascending dose
| Arm | Type | Receives |
|---|---|---|
| HM15275 | Experimental | Drug: HM15275, Drug: Placebo of HM15275Active comparator: Part A: single-ascending dose Single doses of HM15275 in healthy adults administered via subcutaneous injection. Part B: multiple-ascending dose Multiple doses of HM15275 in obese adults administered via subcutaneous injection. |
| Placebo of HM15275 | Placebo comparator | Drug: HM15275, Drug: Placebo of HM15275Placebo comparator: Part A: single-ascending dose Single doses of HM15275 placebo in healthy adults administered via subcutaneous injection. Part B: multiple-ascending dose Multiple doses of HM15275 placebo in obese adults administered via subcutaneous injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female and male adults, ages ≥ 18 and ≤ 65 years.
- Part A: Healthy subjects with body mass index (BMI) ≥ 20.0 kg/m2 and ≤ 27 kg/m2.
- Part B: Obese subjects with BMI ≥ 30.0 kg/m2 and ≤ 45.0 kg/m2 with a stable body weight for 3 months prior to screening (defined as change < 5%).
- HbA1c < 6.5 % [based on American Diabetes Association, 2023].
- Female subjects must be non-pregnant and non-lactating.
Key exclusion criteria (8 listed)
- Subject with existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product.
- Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for < 5 years.
- Subjects with a history of any serious adverse reaction or hypersensitivity to study drug components (includes GLP-1, GIP, glucagon analogs) or have contraindicating diseases.
- Subjects with confirmed type 1 or type 2 diabetes.
- Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within from 24 hours before each study visit and while subjects are confined to the study center.
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 HM15275 |
| Placebo of HM15275A sterile, matching solution supplied in pre-filled syringes. | Drug | HM15275, Placebo of HM15275 |
Primary outcome
Part A: Safety and Tolerability
Time frame: Up to Day 29
Number of participants with treatment-emergent adverse events (TEAEs) after a single subcutaneous dose
Part B: Safety and Tolerability
Time frame: Up to Day 57
Number of participants with treatment-emergent adverse events (TEAEs) after multiple subcutaneous doses
2 secondary outcomes
Part A: Pharmacokinetics
Time frame: Up to Day 29
Part B: Pharmacokinetics
Time frame: Up to Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM15275 in people with Obesity, run by Hanmi Pharmaceutical Company Limited at 1 site 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: finished, as of the sponsor's last update on 22 May 2025. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part A: Safety and Tolerability (time frame: Up to Day 29). 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 22 May 2025.