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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, Germany
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.
Time frame: Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2
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.
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
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.
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
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 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
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.
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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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.