A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
Recruiting
Early Phase 1Interventional Study
Healthy Participants StudyOverweight and Obese AdultsFirst in Man Study to Evaluate Initial Safety
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Male
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
88 (estimated)
Sponsor
Zealand Pharma · Industry
Who this trial is looking for
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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 …
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.
Trial Locations
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Status
Eligibility 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, b…
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
Contacts
Regulatory Affairs Department Regulatory Affairs Department, MDRA
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