Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07219589

Recruiting nowPhase 1Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Obese

Full registry 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.

Treatments and study arms

HM17321

Drug

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

Drug

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 outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Medpace Clinical Pharmacology Unit🇺🇸 Cincinnati, Ohio, United States
Leela VrishabhendraPrincipal Investigator