Actively Recruiting
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
Led by Hanmi Pharmaceutical Company Limited · Updated on 2026-05-04
90
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating HM17321, a urocortine 2 analog, in a Phase 1 study to understand its safety, tolerability, and how it behaves in the body when given in single and multiple doses. The study includes healthy and obese adults to explore the drug's effects and how it is processed in these different populations. This study is randomized, double-blind, and placebo-controlled to carefully monitor responses and side effects. The study has two parts: Part A tests single doses of HM17321 in healthy participants with a body mass index (BMI) between 20 and 27 kg/m², while Part B tests multiple weekly doses over 12 weeks in obese participants with a BMI between 30 and 45 kg/m². Participants receive subcutaneous (under the skin) injections of either HM17321 or a placebo. Part A involves a 5-day inpatient stay and follow-up through Day 29, lasting about 8 weeks total per participant. Part B includes a 12-week treatment period and a 4-week follow-up, with about 22 weeks total per participant. Participants will be screened before enrollment and monitored closely during the study with safety reviews guiding dose escalation. Researchers will track adverse events, drug levels in the blood, and how the body absorbs and processes HM17321. Follow-up includes outpatient visits and assessments through Day 29 in Part A and Day 113 in Part B. The study aims to ensure participant safety while collecting detailed data about the drug's effects over the treatment periods and beyond.
CONDITIONS
Brief Title
A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years
- Part A: Healthy participants with BMI between 20 and 27 kg/m2 at screening
- Part B: Healthy obese participants with BMI between 30 and 45 kg/m2 at screening
- Stable body weight (less than 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
You will not qualify if you...
- History of any bariatric procedure
- Uncontrolled thyroid disease (TSH greater than 6.0 or less than 0.4 mIU/L)
- Abnormal liver function or clinically significant liver disease (Part A: ALT or AST at or above upper limit of normal, or total bilirubin at or above upper limit; Part B: ALT or AST more than twice upper limit, or total bilirubin more than 1.5 times upper limit)
- Abnormal pancreatic function (Part A: amylase or lipase at or above upper limit; Part B: amylase or lipase more than three times upper limit)
- Clinically significant cardiovascular disorders such as heart attack, heart failure, or long QT syndrome
- Abnormal kidney function (eGFR less than 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 more than 14 standard units per week in the past year, or positive drug screen)
- Use of any investigational product within 30 days or 5 half-lives before screening
- Additional exclusions for Part B: HbA1c 6.5% or higher or history of diabetes, obesity caused by other endocrine disorders, recent use of weight control or antihypertensive medications, and lipid-lowering medications unless dose is stable for 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks for Part A; up to 6 weeks for Part B
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days for Part A; 12 weeks for Part B
Participants receive subcutaneous injections of HM17321 or placebo. Part A includes a single dose during a 5-day inpatient stay followed by outpatient monitoring. Part B includes once-weekly doses over 12 weeks.
1 inpatient stay of 5 days (Part A); weekly visits for up to 12 weeks (Part B)
Duration - Up to 24 days for Part A; 4 weeks for Part B
Participants are monitored for safety, tolerability, and pharmacokinetics after treatment completion.
Outpatient visits through Day 29 (Part A); outpatient visits for 4 weeks after treatment (Part B)
Trial Site Locations
Total: 1 location
1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Actively Recruiting
Research Team
J
Jimin Han
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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