Healthy Participants StudyEarly Phase 1NCT07721597
A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
A Early Phase 1 study testing ZP6590, solution for injection in people with Healthy Participants Study and Overweight and Obese Adults, run by Zealand Pharma at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study, Overweight and Obese Adults, First in Man Study to Evaluate Initial Safety
- What is being tested?
- ZP6590, solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jul 2026to 6 Sep 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Regulatory Affairs Department Regulatory Affairs Department, MDRA contact
Regulatory Affairs Department Regulatory Affairs Department contact
Germany1 site, 1 recruiting
- Recruiting
Profil, Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460
Regulatory Affairs Department Regulatory Affairs Department, +49213140180, clinicaltrialservices@profil.com
Project Management Project Management, +49213140180, clinicaltrialservices@profil.com
About this study
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
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?
Read more
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.
Read the 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.
- Conditions
- Healthy Participants Study, Overweight and Obese Adults, First in Man Study to Evaluate Initial Safety
- Being tested
- ZP6590, solution for injection, Placebo, solution for injection
- Keywords
- ZP6590, Safety and Tolerability, GIP-R agonist, obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZP6590, solution for injectionDrug
Participants will receive single or multiple subcutaneous dose administrations of ZP6590.
Placebo, solution for injectionDrug
Participants will receive single or multiple subcutaneous dose administrations of Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Drug: ZP6590, solution for injection | Active comparator | ZP6590 will be administered as single dose administration and as multiple dose administrations. Receives: Drug: ZP6590, solution for injection |
| Placebo, solution for injections | Placebo comparator | Placebo will be administered as single dose administration and as multiple dose administrations. Receives: Drug: Placebo, solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial
Measured: 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 outcomes (21)
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
Measured: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Area under the plasma concentration versus time curve from 0 to last (AUClast)
Measured: SAD Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Peak Plasma Concentration (Cmax)
Measured: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Time to Peak Plasma Concentration (Tmax)
Measured: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Terminal rate constant (λz)
Measured: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Terminal half-life (t½)
Measured: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Apparent volume of distribution during terminal phase (Vz/f)
Measured: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
apparent total clearance of ZP6590 from plasma for SAD cohorts (CL/f)
Measured: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Area under the plasma concentration versus time curve from 0 to trough (AUCτ)
Measured: 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
Peak Plasma Concentration (Cmax)
Measured: 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 to Peak Plasma Concentration (Tmax)
Measured: 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
Trough concentration measured predose for MAD cohorts (Cτ)
Measured: 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)
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
Measured: MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Area under the plasma concentration versus time curve from 0 to last (AUClast)
Measured: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Peak Plasma Concentration (Cmax)
Measured: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Time to Peak Plasma Concentration (Tmax)
Measured: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Terminal rate constant (λz)
Measured: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Terminal half-life (t½)
Measured: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Apparent volume of distribution during terminal phase (Vz/f)
Measured: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Apparent total clearance of ZP6590 from plasma at steady state (SS) for MAD-cohorts (CLss/f)
Measured: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Mean residence time of plasma ZP6590 concentration at steady state (SS) for MAD cohorts (MRTss)
Measured: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start9 Jul 2026
- Primary completion6 Sep 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a randomized, double-blind within cohorts, placebo-controlled, sequential single and multiple ascending dose trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Hövelmann, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721597
- Sponsor's protocol ID
- ZP6590-26033
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided