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RECRUITING
NCT07721597
EARLY_PHASE1

A 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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2026-07-09

Completion Date

2027-09-06

Last Updated

2026-07-23

Healthy Volunteers

Yes

Interventions

DRUG

ZP6590, solution for injection

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

DRUG

Placebo, 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