Safety and Body Processing of ZP6590 Given as Single and Multiple Doses to Adult Men With Normal Weight, Overweight, and Obesity

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes the drug ZP6590 in adult men who are healthy and have a normal weight, are overweight, or have obesity. This randomized, double-blind, placebo-controlled trial aims to understand if ZP6590 is safe and well tolerated when given as increasing single and multiple doses. The study also investigates how quickly and to what extent the drug is absorbed, distributed, and eliminated from the body. The trial has two parts. In the first part, participants receive a single subcutaneous dose of ZP6590 or placebo followed by a 4-week observation period. In the second part, participants receive multiple subcutaneous doses of ZP6590 or placebo for either 6 or 12 weeks, followed by a 6-week observation period after the last dose. Participants are admitted to the study site before dosing and may have ambulatory visits or stay under in-house conditions after dosing. Safety and drug exposure are evaluated before increasing to the next dose level. Participants will undergo screening to confirm eligibility before enrollment. During the study, safety assessments, blood tests, and pharmacokinetic evaluations are performed regularly to monitor the drugs effects and how it is processed in the body. The main outcomes measured are safety and tolerability over the dosing and observation periods. Participants involvement lasts up to 18 weeks depending on the dosing schedule, including observation periods following dosing.

A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity