Status:
TERMINATED
A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
Lead Sponsor:
Zealand Pharma
Collaborating Sponsors:
Profil Institut für Stoffwechselforschung GmbH
Conditions:
Safety and Tolerability
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
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 des...
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 ascen...
Eligibility Criteria
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.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06000891
Start Date
September 15 2023
End Date
March 21 2025
Last Update
April 25 2025
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, Germany, 41460