Clinical trial NCT06000891: A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
Official title: A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Safety and Tolerability
Keywords: GLP-1/GLP-2 agonist, overweight, obesity
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
Collaborators: name: Profil Institut für Stoffwechselforschung GmbH
First posted: 2023-08-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts for Part 1 in a semi-parallel design and one cohort for Part 2.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2
Secondary outcomes:
measure: Pharmacokinetics endpoints related to ZP7570 exposure
timeFrame: 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.
measure: Pharmacokinetics endpoints related to ZP7570 exposure
timeFrame: 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.
measure: Pharmacokinetics endpoints related to ZP7570 exposure
timeFrame: 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.
measure: Pharmacokinetics endpoints related to ZP7570 exposure
timeFrame: 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.
measure: Pharmacokinetics endpoints related to ZP7570 exposure
timeFrame: 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.
measure: Pharmacokinetics endpoints related to ZP7570 exposure
timeFrame: 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.
measure: Pharmacokinetics endpoints related to ZP7570 exposure
timeFrame: 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.)
measure: Pharmacokinetics endpoints related to ZP7570 exposure
timeFrame: 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.
measure: Absolute change in body weight
timeFrame: Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.
measure: Percent change in body weight
timeFrame: Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
state: North Rhine-Westphalia
Study officials:
affiliation: Profil, Neuss, Germany
name: Ulrike Hoevelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: