A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Obesity, Obese

In brief

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.

Key facts

Study ID

NCT07219589

Run by

Hanmi Pharmaceutical Company Limited

People needed

90

Starts

2025-11-06

Expected to finish

2027-03-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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