RecruitingEarly Phase 1NCT07721597

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

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


Sponsor

Zealand Pharma

Enrollment

88 participants

Start Date

Jul 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are: * Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590? * How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body? In the first Part of the study: Participants will: • Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks. In the second Part of the study: Participants will: • Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, solution for injection and a drug called ZP6590, solution for injection for people with first in man study to evaluate initial safety, healthy participants study, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZP6590, solution for injection

Participants will receive single or multiple subcutaneous dose administrations of ZP6590.

DRUGPlacebo, solution for injection

Participants will receive single or multiple subcutaneous dose administrations of Placebo.


Locations(1)

Profil, Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

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NCT07721597


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