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

NCT07721597 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

Principal Investigators

  • Ulrike Hövelmann · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-09
Primary Completion
2027-09-06
Completion
2027-09-06

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721597 on ClinicalTrials.gov