Obesity Clinical Trials

Find Obesity Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

⁃ SAD-Part:

• Male participant

• Age between 18 and 55 years, both inclusive

• Body Mass Index (BMI) between 20.0 and 29.9 kg/m\^2, both inclusive

⁃ MAD-Part:

• Male participant

• Age between 18 and 60 years, both inclusive

• Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2, both inclusive

Locations
Other Locations
Germany
Profil, Institut für Stoffwechselforschung GmbH
RECRUITING
Neuss
Contact Information
Primary
Regulatory Affairs Department Regulatory Affairs Department, MDRA
clinicaltrialservices@profil.com
+49213140180
Backup
Regulatory Affairs Department Regulatory Affairs Department
clinicaltrialservices@profil.com
+49213140180
Time Frame
Start Date: 2026-07-09
Estimated Completion Date: 2027-09-06
Participants
Target number of participants: 88
Treatments
Active_comparator: Drug: ZP6590, solution for injection
ZP6590 will be administered as single dose administration and as multiple dose administrations.
Placebo_comparator: Placebo, solution for injections
Placebo will be administered as single dose administration and as multiple dose administrations.
Related Therapeutic Areas
Sponsors
Leads: Zealand Pharma

This content was sourced from clinicaltrials.gov