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Study of HM17321 in Healthy and Obese Participants

This study is testing a new medication called HM17321 to see how safe it is and how your body handles it. It's for healthy adults aged 18-65. Some participants will be healthy with a normal Body Mass Index (BMI), while others will be healthy but obese (BMI between 30 and 45). You would receive either HM17321 or a placebo (an inactive substance) through injections under the skin. The main goal is to track any side effects. This study is currently in an unclear status regarding recruitment.

Study design
This is a Phase 1, randomized, double-blind, placebo-controlled study involving about 90 participants. It has two parts: one with a single dose and another with multiple doses.
What's involved
You would have a screening period of up to 28 days, a 5-day stay in the hospital for dosing, and then outpatient follow-up for about 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to 29 days after a single dose, and up to 113 days after multiple doses.

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NCT07219589

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Hanmi Pharmaceutical Company Limited
~90 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:HM17321Placebo of HM17321

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321
Measured over Up to Day 29 (Part A); Up to Day 113 (Part B)

Conditions

Obesity
Obese

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Jimin Han
[email protected]
+82-2-410-9838
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321Up to Day 29 (Part A); Up to Day 113 (Part B)

    Number, type, and severity of treatment-emergent adverse events, including changes in vital signs, electrocardiograms, clinical laboratory tests, and immunogenicity assessments following administration of HM17321 or placebo