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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medpace Clinical Pharmacology Unit
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Jimin Han
• Email: jimin.han@hanmi.co.kr
• Phone: +82-2-410-9838

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a new endoscopy technique for bariatric patients

  This study is testing a new, less invasive endoscopy method for bariatric patients to see if it can improve safety and reduce costs when checking for stomach and digestive issues.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT06200961

• Optimizing diet and physical activity for taxi drivers

  This study is trying to help taxi drivers who are overweight or obese make healthier choices about their diet and exercise through personalized support and tools.

  Recruiting Phase 2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT05770570

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.