Recruiting
Phase 1

HM17321

Sponsor:

Hanmi Pharmaceutical Company Limited

Code:

NCT07219589

Conditions

Obesity

Obese

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

HM17321

Placebo of HM17321

Study Details

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.

Conditions

Obesity

Obese

Study ID

NCT07219589

Start date

Nov 6, 2025

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HM17321

placebo comparator: Placebo

Interventions

HM17321

Participants will receive a single or multiple subcutaneous injections of HM17321 at the assigned dose level. HM17321 is provided as a sterile solution in prefilled syringes.

Placebo of HM17321

Participants will receive a single or multiple subcutaneous injections of a matching placebo solution in prefilled syringes. The placebo does not contain any active ingredients.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) Following Single and Multiple Subcutaneous Doses of HM17321 [ Time Frame: Up to Day 29 (Part A); Up to Day 113 (Part B) ]

Central Contacts and Locations

Central contacts

Jimin Han

+82-2-410-9838jimin.han@hanmi.co.kr

Locations

Medpace Clinical Pharmacology Unit

Recruiting

Cincinnati, Ohio, United States, 45227

Principal Investigator:

Leela Vrishabhendra

More Information

Sponsor

Hanmi Pharmaceutical Company Limited

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Obese
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hanmi Pharmaceutical Company Limited on 2026-05-04.