Testing HM17321 injections to find safe dose ranges in healthy and obese adults

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM17321 in Healthy and Obese Participants

This study will try single and multiple doses of HM17321 injections in healthy adults and adults with obesity to see if they are safe and how the body processes the drug.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hanmi Pharmaceutical Company Limited (Industry-sponsored)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT07219589 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 single and multiple ascending dose study of HM17321, a urocortin 2 (UCN2) analog, given by subcutaneous injection. The trial has two parts: Part A enrolls about 40 healthy adults (BMI 20–27 kg/m²) across five single-dose cohorts with sentinel dosing and 6:2 randomization to active or placebo, and Part B enrolls about 50 adults with obesity (BMI 30–45 kg/m²) across five multiple-dose cohorts. Safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) will guide dose escalation decisions made by a Safety Review Committee. Each participant undergoes screening, inpatient dosing (Part A: 5-day stay), and outpatient follow-up through approximately Day 29, with about 90 participants planned in total.

Who should consider this trial

Good fit: Adults 18–65 who are either healthy with BMI 20–27 kg/m² (Part A) or meet obesity criteria with BMI 30–45 kg/m² (Part B), have stable weight for the prior 3 months, and meet laboratory and contraceptive requirements are ideal candidates.

Not a fit: People with prior bariatric surgery, significant liver or pancreatic disease, uncontrolled thyroid disease, pregnant or breastfeeding individuals, or those outside the BMI ranges would not be eligible and are unlikely to benefit from participation.

Why it matters

Potential benefit: If HM17321 is safe and shows favorable pharmacology, it could become a new injectable option that affects weight-related physiology and metabolic targets.

How similar studies have performed: Urocortin-2 analogue approaches are relatively novel with limited prior human obesity data, so clinical benefit for weight loss remains unproven.

Eligibility 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.

Where this trial is running

Cincinnati, Ohio

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

Study contacts

• Study coordinator: Jimin Han

Conditions Obesity; Obese