drugset / Trial / NCT06000891
A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
Phase 1
Terminated
84 enrolled
Zealand Pharma
Profil Institut für Stoffwechselforschung GmbH · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2023-09-15
- Primary completion
- 2025-02-11
- Completion
- 2025-03-21
Outcome
Outcome not reported
Stopped: “Decision by Sponsor; LSLV was completed on 21-Mar-2025 as planned.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ZP7570 | Unknown | — | Subcutaneous |
Indications
No indication recorded.