A Phase I Single‑and Multiple‑Ascending Dose Study of ZP6590 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Adults with Overweight/Obesity

The primary objective is to evaluate safety and tolerability of ZP6590 following single and multiple dosing in individuals undergoing weight management, providing essential information on the risk profile of the investigational agent. Secondary objectives include characterization of the pharmacokinetics of ZP6590 and assessment of its pharmacodynamics, which will inform exposure‑response relationships and support further clinical development.

All participants were male and comprised both patients and healthy volunteers relevant to weight management. The protocol defined an age range, but specific limits are not disclosed. The sponsor did not provide the total number of enrolled subjects. Selection incorporated standard health assessments, with exclusion of individuals whose conditions could interfere with weight outcomes. Lifestyle factors such as diet and physical activity were recorded, without imposing specific requirements.

The study is a Phase 1, randomized, double‑blind, placebo‑controlled trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ZP6590 in subjects undergoing weight management. Recruitment is planned to begin on 1 July 2026 and conclude by 30 June 2027, with each participant remaining in the study for approximately 8 weeks, encompassing a screening visit, a baseline dosing visit, multiple follow‑up assessments at weeks 2, 4 and 6, and a final end‑of‑study visit at week 8. The screening visit confirms eligibility criteria, while subsequent visits monitor vital signs, laboratory parameters, adverse events and drug concentration levels to assess pharmacodynamic effects. Participants may be withdrawn early for predefined reasons such as significant adverse events, protocol non‑compliance, or the investigator’s determination of unacceptable risk. All data collection follows a predefined schedule to ensure consistency across the trial cohort.