A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
Recruiting · NCT07219589 · Interventional (participants receive a specific treatment) · Lead sponsor: Hanmi Pharmaceutical Company Limited
View the official record on ClinicalTrials.gov →Interventions studied
HM17321Placebo of HM17321
What this trial is about
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 take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Medpace Clinical Pharmacology Unit - Cincinnati, Ohio, United States