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

Safety and Tolerability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000891
• Other study ID #: ZP7570-23012
• Secondary ID: 2022-500614-26
• Status: Recruiting
• Phase: Phase 1
• Start date: September 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: September 2023
• Source: Zealand Pharma
• Contact: Anne Sager, CTM
• Phone: +45 5060
• Email: ASager[@]zealandpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. All subjects will be dosed for 13 weeks with ascending weekly doses of ZP7570 at dose levels with corresponding volume of placebo.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Safety and Tolerability

Intervention

Drug:
• ZP7570
13 once-weekly subcutaneous injections
• Placebo
13 once-weekly subcutaneous injections

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss	North Rhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
Zealand Pharma	Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 1 to Day 127
Secondary	Pharmacokinetics endpoints related to ZP7570 exposure	Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 18 weeks (Day 127) .	Area under the drug concentration curve from baseline to 18 weeks (Day 1 predose to Day 127)
Secondary	Pharmacokinetics endpoints related to ZP7570 exposure	Pharmacokinetics - Maximum plasma concentration (peak) from baseline (Day 1, predose) to 18 weeks (Day 127).	Maximum drug concentration (Cmax) from baseline to 18 weeks (Day 1, predose to Day 127)
Secondary	Pharmacokinetics endpoints related to ZP7570 exposure	Pharmacokinetics - Time to maximum plasma concentration (Tmax) from baseline (Day 1, predose) to 18 weeks (Day 127).	Time to maximum plasma concentration from baseline to 18 weeks (Day 1, predose to Day 127)
Secondary	Pharmacokinetics endpoints related to ZP7570 exposure	Pharmacokinetics - Elimination rate constant (?z) from baseline (Day 1, predose) to 18 weeks (Day 127).	Elimination rate constant from baseline to 18 weeks (Day 1, predose to Day 127)
Secondary	Pharmacokinetics endpoints related to ZP7570 exposure	Pharmacokinetics - Elimination half-life (t1/2) from baseline (Day 1, predose) to 18 weeks (Day 127).	Elimination half-life from baseline to 18 weeks (Day 1, predose to Day 127)
Secondary	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).	Apparent volume of distribution from baseline to 18 weeks (Day 1, predose to Day 127))
Secondary	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).	Apparent total clearance of the drug from plasma from baseline to 18 weeks (Day 1, predose to Day 127)
Secondary	Pharmacokinetics endpoints related to ZP7570 exposure	Pharmacokinetics - Trough concentration measured predose (Ctrough) from baseline (Day 1, predose) to 18 weeks (Day 127).	Trough concentration measured from baseline to 18 weeks (Day 1, predose to Day 127)
Secondary	Absolute change in body weight	Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 92)	Day 1 and Day 92
Secondary	Percent change in body weight	Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 92)	Day 1 and Day 92