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

Phase 1

Terminated

• Conditions: Safety and Tolerability
• Interventions: Drug: ZP7570; Drug: Placebo

• Registration Number: NCT06000891
• Lead Sponsor: Zealand Pharma

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-21
• Study Start: 2023-09-15
• Primary Completion: 2025-02-11
• Study Completion: 2025-03-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZP7570	ZP7570	ZP7570 for subcutaneous once-weekly injection.
Placebo	Placebo	Placebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events (TEAEs)	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics endpoints related to ZP7570 exposure	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.	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.
Absolute change in body weight	Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.	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.
Percent change in body weight	Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.	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.

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, North Rhine-Westphalia, Germany