NCT07219589RecruitingPhase 1
A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
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
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 16 Oct 2025
- Start date
- 6 Nov 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Diseases
- Obesity
- NCT number
- NCT07219589
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 90
- From 6 Nov 2025 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to screening.
Other illness
- History of any bariatric procedure.
- Uncontrolled thyroid disease (TSH \>6.0 or \<0.4 mIU/L).
- Positive test for hepatitis B, hepatitis C, or HIV at screening.
- History of drug or alcohol abuse within defined timeframes (e.g., alcohol \>14 standard units/week in past year, or positive drug screen).
Lab values
- 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).
- 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.
Other
- Women who are pregnant, planning to become pregnant, or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medpace Clinical Pharmacology Unit Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.