ObesityPhase 1NCT07219589
A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
A Phase 1 study testing HM17321 in people with Obesity and Obese, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 after single and multiple ascending doses in healthy and obese participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- HM17321
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to Mar 2027
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Part A: Healthy participants with BMI ≥20 kg/m² and ≤27 kg/m² at screening.
- Part B: Healthy obese participants with BMI ≥30 kg/m² and ≤45 kg/m² at screening.
- Stable body weight (<5% change) in the past 3 months.
- Able and willing to provide written informed consent.
- Male participants must use contraception or remain abstinent from women of childbearing potential.
- Female participants must not be pregnant or breastfeeding and use highly effective contraception if of childbearing potential.
Who cannot join
- History of any bariatric procedure.
- Uncontrolled thyroid disease (TSH >6.0 or <0.4 mIU/L).
- Abnormal liver function or clinically significant liver disease
- Part A: ALT or AST ≥ ULN, or total bilirubin ≥ ULN
- Part B: ALT or AST >2× ULN, or total bilirubin >1.5× ULN
- Abnormal pancreatic function
Show all 19Show fewer
- Part A: amylase or lipase ≥ ULN
- Part B: amylase or lipase >3× ULN
- Clinically significant cardiovascular disorders (e.g., myocardial infarction, congestive heart failure, long QT syndrome).
- Abnormal renal function (eGFR <60 mL/min/1.73 m²).
- Positive test for hepatitis B, hepatitis C, or HIV at screening.
- Women who are pregnant, planning to become pregnant, or breastfeeding.
- History of drug or alcohol abuse within defined timeframes (e.g., alcohol >14 standard units/week in past year, or positive drug screen).
- Use of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to screening.
- Additional Exclusion Criteria for Part B
- HbA1c ≥6.5% or a history of diabetes mellitus (type 1 or type 2).
- Obesity induced by other endocrine disorders (e.g., Cushing syndrome).
- Use of weight control treatments (e.g., GLP-1 receptor agonists or other anti-obesity medications) and antihypertensive medications within 3 months prior to screening.
- Use of any lipid-lowering medications, unless on a stable dose for at least 3 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
Leela Vrishabhendra
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM17321 in Healthy and Obese Participants
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 after single and multiple ascending doses in healthy and obese participants.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321, a urocortine 2 (UCN2) analog, administered by subcutaneous (SC) injection in healthy and obese participants.
The study consists of two parts: Part A (Single Ascending Dose) and Part B (Multiple Ascending Dose), with approximately 90 participants to be enrolled in total.
In Part A, approximately 40 healthy participants with a body mass index (BMI) of ≥20 kg/m² and ≤27 kg/m² will be enrolled across 5 sequential dose cohorts. Each cohort will consist of approximately 8 participants randomized in a 6:2 ratio to receive a single SC dose of HM17321 or placebo. A sentinel dosing strategy will be applied in each cohort to ensure participant safety, with initial safety data reviewed prior to dosing the remainder of the cohort. Dose escalation decisions will be made by a Safety Review Committee (SRC) based on safety, tolerability, and available PK data. Part A will include a screening period of up to 28 days, a 5-day inpatient stay with single SC dosing, and an outpatient follow-up period through Day 29, with an overall study duration of approximately 8 weeks per participant.
In Part B, approximately 50 healthy obese participants with a BMI of ≥30 kg/m² and ≤45 kg/m² will be enrolled across 5 sequential dose cohorts. Each cohort will consist of approximately 10 participants randomized in an 8:2 ratio to receive once-weekly SC doses of HM17321 or placebo over a 12-week treatment period. Dose escalation will be guided by SRC review of safety, tolerability, and PK data at predefined time points. Part B will include a screening period of up to 45 days, a 12-week treatment period with once-weekly SC dosing, and a 4-week follow-up period through Day 113, with an overall study duration of approximately 22 weeks per participant.
- Being tested
- HM17321, Placebo of HM17321
- 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.
HM17321Drug
Participants will receive a single or multiple subcutaneous injections of HM17321 at the assigned dose level. HM17321 is provided as a sterile solution in prefilled syringes.
Placebo of HM17321Drug
Participants will receive a single or multiple subcutaneous injections of a matching placebo solution in prefilled syringes. The placebo does not contain any active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| HM17321 | Experimental | Not described Receives: Drug: HM17321 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo of HM17321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321
Number, type, and severity of treatment-emergent adverse events, including changes in vital signs, electrocardiograms, clinical laboratory tests, and immunogenicity assessments following administration of HM17321 or placebo
Measured: Up to Day 29 (Part A); Up to Day 113 (Part B)
Secondary outcomes (3)
Peak Plasma Concentration (Cmax) of HM17321
Maximum observed plasma concentration of HM17321 following single and multiple subcutaneous doses.
Measured: Up to Day 29 (Part A); Up to Day 113 (Part B)
Time to Maximum Plasma Concentration (Tmax) of HM17321
Time to reach maximum observed plasma concentration following single and multiple subcutaneous doses.
Measured: Up to Day 29 (Part A); Up to Day 113 (Part B)
Area Under Plasma Concentration-Time Curve (AUC) of HM17321
Area under the plasma concentration-time curve from time zero to the last measurable concentration following single and multiple subcutaneous doses.
Measured: Up to Day 29 (Part A); Up to Day 113 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start6 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
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
- Participants in each cohort will be randomly assigned to receive either HM17321 or placebo. Dose levels will be escalated sequentially in separate cohorts after review of safety data.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 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
- NCT07219589
- Sponsor's protocol ID
- HM-UCN2-101
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2025
- Last updated
- 4 May 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 4 May 2026. 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 Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM17321 in Healthy and Obese Participants
- ClinicalTrials.gov ID
- NCT07219589
- Acronym / sponsor ID
- HM-UCN2-101
- Keywords
- Obese, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 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 is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 after single and multiple ascending doses in healthy and obese participants.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321, a urocortine 2 (UCN2) analog, administered by subcutaneous (SC) injection in healthy and obese participants.
The study consists of two parts: Part A (Single Ascending Dose) and Part B (Multiple Ascending Dose), with approximately 90 participants to be enrolled in total.
In Part A, approximately 40 healthy participants with a body mass index (BMI) of ≥20 kg/m² and ≤27 kg/m² will be enrolled across 5 sequential dose cohorts. Each cohort will consist of approximately 8 participants randomized in a 6:2 ratio to receive a single SC dose of HM17321 or placebo. A sentinel dosing strategy will be applied in each cohort to ensure participant safety, with initial safety data reviewed prior to dosing the remainder of the cohort. Dose escalation decisions will be made by a Safety Review Committee (SRC) based on safety, tolerability, and available PK data. Part A will include a screening period of up to 28 days, a 5-day inpatient stay with single SC dosing, and an outpatient follow-up period through Day 29, with an overall study duration of approximately 8 weeks per participant.
In Part B, approximately 50 healthy obese participants with a BMI of ≥30 kg/m² and ≤45 kg/m² will be enrolled across 5 sequential dose cohorts. Each cohort will consist of approximately 10 participants randomized in an 8:2 ratio to receive once-weekly SC doses of HM17321 or placebo over a 12-week treatment period. Dose escalation will be guided by SRC review of safety, tolerability, and PK data at predefined time points. Part B will include a screening period of up to 45 days, a 12-week treatment period with once-weekly SC dosing, and a 4-week follow-up period through Day 113, with an overall study duration of approximately 22 weeks per participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in each cohort will be randomly assigned to receive either HM17321 or placebo. Dose levels will be escalated sequentially in separate cohorts after review of safety data.
| Arm | Type | Receives |
|---|---|---|
| HM17321 | Experimental | Drug: HM17321 |
| Placebo | Placebo comparator | Drug: Placebo of HM17321 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18-65 years.
- Part A: Healthy participants with BMI ≥20 kg/m² and ≤27 kg/m² at screening.
- Part B: Healthy obese participants with BMI ≥30 kg/m² and ≤45 kg/m² at screening.
- Stable body weight (<5% change) in the past 3 months.
- Able and willing to provide written informed consent.
Key exclusion criteria (19 listed)
- History of any bariatric procedure.
- Uncontrolled thyroid disease (TSH >6.0 or <0.4 mIU/L).
- Abnormal liver function or clinically significant liver disease
- Abnormal pancreatic function
- Clinically significant cardiovascular disorders (e.g., myocardial infarction, congestive heart failure, long QT syndrome).
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 |
|---|---|---|
| HM17321Participants will receive a single or multiple subcutaneous injections of HM17321 at the assigned dose level. HM17321 is provided as a sterile solution in prefilled syringes. | Drug | HM17321 |
| Placebo of HM17321Participants will receive a single or multiple subcutaneous injections of a matching placebo solution in prefilled syringes. The placebo does not contain any active ingredients. | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321
Time frame: Up to Day 29 (Part A); Up to Day 113 (Part B)
Number, type, and severity of treatment-emergent adverse events, including changes in vital signs, electrocardiograms, clinical laboratory tests, and immunogenicity assessments following administration of HM17321 or placebo
3 secondary outcomes
Peak Plasma Concentration (Cmax) of HM17321
Time frame: Up to Day 29 (Part A); Up to Day 113 (Part B)
Time to Maximum Plasma Concentration (Tmax) of HM17321
Time frame: Up to Day 29 (Part A); Up to Day 113 (Part B)
Area Under Plasma Concentration-Time Curve (AUC) of HM17321
Time frame: Up to Day 29 (Part A); Up to Day 113 (Part B)
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 4 May 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 1 study testing HM17321 in people with Obesity and Obese, 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 7 inclusion and 19 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 4 May 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 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?
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 Jimin Han (+82-2-410-9838, jimin.han@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321 (time frame: Up to Day 29 (Part A); Up to Day 113 (Part B)). 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 4 May 2026.