A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZP6590, solution for injection, Placebo, solution for injection.
- Who it may be relevant to
- Registry conditions: Healthy Participants Study, Overweight and Obese Adults, First in Man Study to Evaluate Initial Safety. Basic parameters: 18 years — 60 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
The main objective of this randomized, double-blind, placebo-controlled trial is to assess the safety and tolerability of drug ZP6590 as single ascending doses and multiple ascending doses in healthy participants living with normal weight, overweight and obesity.
In addition, the study will investigate the pharmacokinetics of the drug ZP6590.
The trial is divided in two parts:
SAD-Part 1: Participants will be administered a single subcutaneous dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
MAD-Part 2: Participants will be administered multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
After informed consent has been obtained, eligibility of the participants will be assessed during a screening visit.
SAD- and MAD-Part: Eligible participants will be admitted to the site in the morning on Day before dosing and will have ambulatory visits or remain under in-house conditions after dosing.
Safety evaluation for dose escalation:
The safety and exposure assessments of each cohort will take place before dose escalation to the next dose level will start.
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.
Primary outcome measures
- Safety and Tolerability [Time frame: 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]
Secondary outcome measures (12)
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection [Time frame: SAD-Part: From Day 1 to Day 29]
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection [Time frame: SAD Part: From Day 1 to Day 29]
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection [Time frame: SAD-Part: From Day 1 to Day 29]
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection [Time frame: SAD-Part: From Day 1 to Day 29]
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection [Time frame: SAD-Part: From Day 1 to Day 29]
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection [Time frame: SAD-Part: From Day 1 to Day 29]
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection [Time frame: SAD-Part: From Day 1 to Day 29]
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection [Time frame: SAD-Part: From Day 1 to Day 29]
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections [Time frame: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.]
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections [Time frame: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours]
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections [Time frame: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours]
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections [Time frame: MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)]
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, 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Profil, Institut für Stoffwechselforschung GmbH — Neuss
Identifiers
NCT: NCT07721597 · ZP6590-26033