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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07721597

Enrollment

Registered

2026-07-23

Start date

2026-07-09

Completion date

2027-09-06

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First in Man Study to Evaluate Initial Safety, Healthy Participants Study, Overweight and Obese Adults

Keywords

ZP6590, Safety and Tolerability, GIP-R agonist, obesity

Brief 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.

Detailed description

The main objective of this randomized, double-blind, placebo-controlled trial is to assess the safety and tolerability of drug ZP6590 as single ascending doses and multiple ascending doses in healthy participants living with normal weight, overweight and obesity. In addition, the study will investigate the pharmacokinetics of the drug ZP6590. The trial is divided in two parts: SAD-Part 1: Participants will be administered a single subcutaneous dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks. MAD-Part 2: Participants will be administered multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing. After informed consent has been obtained, eligibility of the participants will be assessed during a screening visit. SAD- and MAD-Part: Eligible participants will be admitted to the site in the morning on Day before dosing and will have ambulatory visits or remain under in-house conditions after dosing. Safety evaluation for dose escalation: The safety and exposure assessments of each cohort will take place before dose escalation to the next dose level will start.

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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Trial safety group is masked to make decision on dose escalation.

Intervention model description

This is a randomized, double-blind within cohorts, placebo-controlled, sequential single and multiple ascending dose trial.

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

SAD-Part and MAD-Part: * Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator * Treatment for weight management within 3 months before randomization in this trial

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability	Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120	Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial

Secondary

Measure	Time frame	Description
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection	SAD-Part: From Day 1 to Day 29	Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections	MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.	Area under the plasma concentration versus time curve from 0 to trough (AUCτ)

Countries

Germany

Contacts

CONTACTRegulatory Affairs Department Regulatory Affairs Department, MDRA

clinicaltrialservices@profil.com+49213140180

CONTACTRegulatory Affairs Department Regulatory Affairs Department