NCT07219589 A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
| NCT ID | NCT07219589 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2025-11-06 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07219589 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07219589 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07219589 currently recruiting?
Yes, NCT07219589 is actively recruiting participants. Contact the research team at jimin.han@hanmi.co.kr for enrollment information.
Where is the NCT07219589 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT07219589 clinical trial?
NCT07219589 is sponsored by Hanmi Pharmaceutical Company Limited. The trial plans to enroll 90 participants.
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