NCT06000891

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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 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.

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

Interventions

Type	Name	Description
DRUG	ZP7570	13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.
DRUG	Placebo	13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

Timeline

• Start date: 2023-09-15
• Primary completion: 2025-02-11
• Completion: 2025-03-21
• First posted: 2023-08-21
• Last updated: 2025-04-25

Locations

1 site across 1 country: Germany