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

Korábbi kezelés

• Use of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to screening.

Más betegség

• History of any bariatric procedure.
• Uncontrolled thyroid disease (TSH >6.0 or <0.4 mIU/L).
• Positive test for hepatitis B, hepatitis C, or HIV at screening.
• History of drug or alcohol abuse within defined timeframes (e.g., alcohol >14 standard units/week in past year, or positive drug screen).

Laborértékek

• 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).
• 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.

Egyéb

• Women who are pregnant, planning to become pregnant, or breastfeeding.

• 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.