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

ConditionsObesityObese
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHanmi Pharmaceutical Company Limited

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HM17321
  • Placebo of HM17321

Treatment groups

90 Participants
are divided into 2 treatment groups