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A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

NCT06000891 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-04-25

No results posted yet for this study

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.

Conditions

  • Safety and Tolerability

Interventions

DRUG

ZP7570

13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

DRUG

Placebo

13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • Zealand Pharma

    lead INDUSTRY

Principal Investigators

  • Ulrike Hoevelmann, MD · Profil, Neuss, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2025-02-11
Completion
2025-03-21

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000891 on ClinicalTrials.gov