NCT07219589 · Hanmi Pharmaceutical Company Limited
A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
What this study is about
This is a Phase 1 study to evaluate the safety, tolerability, how the drug moves through the body, and how the drug affects the body of HM17321 after single and multiple ascending doses in healthy and obese participants.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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.
Where
- Cincinnati, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations