A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and P… (NCT07721597) | Clinical Trial Compass
RecruitingEarly 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
Germany88 participantsStarted 2026-07-09
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability
Timeframe: 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
Trial details
NCT IDNCT07721597
SponsorZealand Pharma
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-09-06
Contact for this trial
Regulatory Affairs Department Regulatory Affairs Department, MDRA