A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
Reason given: Decision by Sponsor; LSLV was completed on 21-Mar-2025 as planned.
Key facts
- Where
- Neuss, GermanySee the site
- Phase
- Phase 1
Where in Germany
- Profil Institut für Stoffwechselforschung GmbHNeuss, GermanyNo longer taking part
Trial details
- Who runs it
- Zealand Pharma
- Trial code
- NCT06000891
- Record updated
- 25 April 2025
- Original description
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.Read full original descriptionShow less
A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity
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.
Inclusion: 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: 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.