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

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.

Study Overview

• Status: Terminated
• Conditions: Safety and Tolerability
• Intervention / Treatment: Drug: ZP7570; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ZP7570; ZP7570 for subcutaneous once-weekly injection.	Drug: ZP7570; 13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.; Other Names: GLP-1/GLP-2 agonist
Placebo Comparator: Placebo; Placebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment	Drug: Placebo; 13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.

Collaborators and Investigators

• Sponsor: Zealand Pharma
• Collaborators: Profil Institut für Stoffwechselforschung GmbH
• Investigators: Principal Investigator: Ulrike Hoevelmann, MD, Profil, Neuss, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: GLP-1/GLP-2 agonist, overweight, obesity
• Other Study ID Numbers: ZP7570-23012; 2022-500614-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No