Safety and TolerabilityPhase 1NCT06000891

A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

A Phase 1 study testing ZP7570 in people with Safety and Tolerability, run by Zealand Pharma at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Safety and Tolerability
What is being tested?: ZP7570
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 siteGermany
Study dates: 15 Sep 2023to 21 Mar 2025
Phase: Phase 1
Are there results?: None posted in the registry

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 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age between 18 and 64 years, both inclusive.
Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive.
In overall good health according to age (medical history, physical and neurological examination, vital signs, and laboratory assessments), as judged by the investigator at screening.

Who cannot join

History of gastrointestinal (GI) diseases including functional complaints that could interfere with the pharmacokinetics of the IMP or auxiliary medicinal product (acetaminophen) of the trial.
Any relevant abnormal renal parameters in the following ranges:
Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR) below 60.0 l/min/1.73m2, as defined by CKD-EPI.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460

Other trials in Germany

About this study

Official title: A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity

The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo within each cohort where the observational period is 18 weeks for Part 1 and 28 weeks for Part 2. All subjects will be dosed for 13 weeks in Part 1 and for 28 weeks in Part 2 with ascending weekly doses of ZP7570 at dose levels with corresponding volume of placebo.

Read the detailed description

ZP7570 is a dual GLP-1R/GLP-2R agonist in clinical development for weight management. The overall purpose of this trial is to evaluate the safety and tolerability when applying dose titration of ascending doses of ZP7570 and at steady state.

The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with corresponding volume of placebo. After informed consent has been obtained, eligibility of the subjects will be assessed during a screening Visit (V1). Additional tests to assess safety and PK and PD will take place during in-house visits and ambulatory visits.

Conditions: Safety and Tolerability
Being tested: ZP7570, Placebo
Keywords: GLP-1/GLP-2 agonist, overweight, 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.

ZP7570Drug
Also called GLP-1/GLP-2 agonist
13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.
PlaceboDrug
13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

Study groups in NCT06000891
Study group	Role	What they receive
ZP7570	Active comparator	ZP7570 for subcutaneous once-weekly injection. Receives: Drug: ZP7570
Placebo	Placebo comparator	Placebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of treatment emergent adverse events (TEAEs)
Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 127) in Part 1.
Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 232) in Part 2.
Measured: Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2

Secondary outcomes (10)

Pharmacokinetics endpoints related to ZP7570 exposure
Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1.
Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2.
Measured: Area under the drug concentration curve from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Pharmacokinetics - Maximum plasma concentration (peak) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1.
Pharmacokinetics - Maximum plasma concentration (peak) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2.
Measured: Maximum drug concentration (Cmax) from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Pharmacokinetics - Time to maximum plasma concentration (Tmax) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1.
Pharmacokinetics - Time to maximum plasma concentration (Tmax) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2.
Measured: Time to maximum plasma concentration from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Pharmacokinetics - Elimination rate constant (λz) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1.
Pharmacokinetics - Elimination rate constant (λz) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2.
Measured: Elimination rate constant from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Pharmacokinetics - Elimination half-life (t1/2) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1.
Pharmacokinetics - Elimination half-life (t1/2) from baseline (Day 1, predose) to 22 weeks (Day 232) in Part 2.
Measured: Elimination half-life from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Pharmacokinetics - Apparent volume of distribution (Vz/f) during the terminal phase from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1.
Pharmacokinetics - Apparent volume of distribution (Vz/f) during the terminal phase from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2.
Measured: Apparent volume of distribution from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Pharmacokinetics - Apparent total clearance of the drug from plasma (Cl/f) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1.
Pharmacokinetics - Apparent total clearance of the drug from plasma (Cl/f) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2.
Measured: Apparent total clearance of the drug from plasma from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.)
Pharmacokinetics endpoints related to ZP7570 exposure
Pharmacokinetics - Trough concentration measured predose (Ctrough) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1.
Pharmacokinetics - Trough concentration measured predose (Ctrough) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2.
Measured: Trough concentration measured from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Absolute change in body weight
Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 92) in Part 1.
Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 197) in Part 2.
Measured: Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.
Percent change in body weight
Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 92) in Part 1.
Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 197) in Part 2.
Measured: Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202321 Mar 2025

First posted21 Aug 2023
Study start15 Sep 2023
Primary completion11 Feb 2025
Study completion21 Mar 2025

Why it stopped: Decision by Sponsor; LSLV was completed on 21-Mar-2025 as planned.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Safety and TolerabilityStudies 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: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts for Part 1 in a semi-parallel design and one cohort for Part 2.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06000891
Sponsor's protocol ID: ZP7570-23012
Other IDs: 2022-500614-26
Status last verified: Apr 2025
First submitted: 8 Aug 2023
Last updated: 25 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data collection and handling of clinical trial data at the trial site has been designed to limit the possibility of identifying trial subjects from their data. To this end, pseudonymised data will be used wherever possible and the collection of demographic information that could be used for re-identification of subjects will be restricted to the extent necessary for the conduct of this trial.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity
ClinicalTrials.gov ID: NCT06000891
Acronym / sponsor ID: ZP7570-23012
Conditions: Safety and Tolerability
Keywords: GLP-1/GLP-2 agonist, overweight, obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Decision by Sponsor; LSLV was completed on 21-Mar-2025 as planned.
Enrolment: 84 participants (actual)
Lead sponsor: Zealand PharmaIndustry (pharma, biotech, devices)
Collaborators: Profil Institut für Stoffwechselforschung GmbH
Study start: 15 Sep 2023 (actual)
Primary completion: 11 Feb 2025 (actual)
Study completion: 21 Mar 2025 (actual)
First posted: 21 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with corresponding volume of placebo. After informed consent has been obtained, eligibility of the subjects will be assessed during a screening Visit (V1). Additional tests to assess safety and PK and PD will take place during in-house visits and ambulatory visits.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts for Part 1 in a semi-parallel design and one cohort for Part 2.

Arm	Type	Receives
ZP7570	Active comparator	Drug: ZP7570ZP7570 for subcutaneous once-weekly injection.
Placebo	Placebo comparator	Drug: PlaceboPlacebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Age between 18 and 64 years, both inclusive.
Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive.
In overall good health according to age (medical history, physical and neurological examination, vital signs, and laboratory assessments), as judged by the investigator at screening.

Key exclusion criteria (3 listed)

History of gastrointestinal (GI) diseases including functional complaints that could interfere with the pharmacokinetics of the IMP or auxiliary medicinal product (acetaminophen) of the trial.
Any relevant abnormal renal parameters in the following ranges:
Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR) below 60.0 l/min/1.73m2, as defined by CKD-EPI.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZP7570Also: GLP-1/GLP-2 agonist13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.	Drug	ZP7570
Placebo13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.	Drug	Placebo

Primary outcome

Incidence of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2
Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 127) in Part 1. Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 232) in Part 2.

10 secondary outcomes

Pharmacokinetics endpoints related to ZP7570 exposure
Time frame: Area under the drug concentration curve from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Time frame: Maximum drug concentration (Cmax) from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Time frame: Time to maximum plasma concentration from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Time frame: Elimination rate constant from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Time frame: Elimination half-life from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Time frame: Apparent volume of distribution from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Pharmacokinetics endpoints related to ZP7570 exposure
Time frame: Apparent total clearance of the drug from plasma from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.)
Pharmacokinetics endpoints related to ZP7570 exposure
Time frame: Trough concentration measured from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.
Absolute change in body weight
Time frame: Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.
Percent change in body weight
Time frame: Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.

Results and safety

The study was stopped early (reason given: Decision by Sponsor; LSLV was completed on 21-Mar-2025 as planned.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
Individual participant dataSharing planned: No. The data collection and handling of clinical trial data at the trial site has been designed to limit the possibility of identifying trial subjects from their data. To this end, pseudonymised data will be used wherever possible and the collection of demographic information that could be used for re-identification of subjects will be restricted to the extent necessary for the conduct of this trial.

Related trials for Safety and Tolerability

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Not yet recruitingPhase 1
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ulrike Hoevelmann, MD principal investigator

Profil, Neuss, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZP7570 in people with Safety and Tolerability, run by Zealand Pharma at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Decision by Sponsor; LSLV was completed on 21-Mar-2025 as planned.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent adverse events (TEAEs) (time frame: Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06000891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.