Phase 1 Study of HM17321 Drug Safety and Effects in Healthy and Obese Adults Given Single and Multiple Doses

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 drugs 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 kgm, while Part B tests multiple weekly doses over 12 weeks in obese participants with a BMI between 30 and 45 kgm. 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 drugs effects over the treatment periods and beyond.

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