NCT07721597RecruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 16 Jul 2026
- Start date
- Jul 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Zealand Pharma
- Diseases
- Obesity
- NCT number
- NCT07721597
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 88
- From Jul 2026 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment for weight management within 3 months before randomization in this trial
Other
- SAD-Part and MAD-Part:
- Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.