ZP6590 safety and dosing in adults with varying weight
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
Run by Zealand Pharma · NCT07721597 · Data updated 2026-11-12
This study tests ZP6590 in adults with normal weight, overweight, and obesity to see if it is safe and tolerable and to understand how the drug behaves in the body.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | Men only |
| Enrollment | 88 (estimated) |
| Sponsor | Zealand Pharma Industry-sponsored |
| Locations | 1 site (Neuss, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | July 9, 2026 |
| Main results expected | September 6, 2027 |
| Study ends | September 6, 2027 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07721597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult males aged 18–60 with BMI 27.0–39.9 kg/m2 for MAD and 18–55 with BMI 20.0–29.9 kg/m2 for SAD, without significant medical abnormalities.
✕Probably not a fit
Participants with significant abnormal lab results or recent weight-management treatment may not benefit and could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase, randomized, double-blind study evaluates single ascending doses and multiple ascending doses of ZP6590 or placebo in healthy adults across weight groups. The trial has two parts: a SAD phase with single injections and a MAD phase with several weeks of dosing, each followed by observation periods. Primary aims are safety, tolerability, plus pharmacokinetics and pharmacodynamics, to determine dose escalation safety and how the drug is absorbed, distributed, metabolized, and eliminated.
Why it matters
Potential benefit: If successful, participants may experience information that supports safe dose ranges for future studies of ZP6590 in obesity.
How similar studies have gone: Previous early-phase studies with GIP-R agonists have gathered safety and PK data in humans, supporting this approach's feasibility but each agent is evaluated separately.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Profil, Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Principal investigator: Ulrike Hövelmann — Profil Institut für Stoffwechselforschung GmbH
- Study coordinator: Regulatory Affairs Department Regulatory Affairs Department, MDRA
- Email: clinicaltrialservices@profil.com
- Phone: +49213140180
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.