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A Trial Comparing Pharmacokinetics, Safety and Tolerability of Two Subcutaneous Concentrations of Dapiglutide

NCT06758583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-06

No results posted yet for this study

Summary

This is a phase 1, open-label, single-center, randomized, parallel-group trial designed to investigate the pharmacokinetic profiles, safety, and tolerability of a single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL. The trial will be conducted in participants with a BMI ≥ 27.0 kg/m2.

Conditions

  • Overweight and Obesity

Interventions

DRUG

Dapiglutide 7.5 mg

Single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL.

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • Zealand Pharma

    lead INDUSTRY

Principal Investigators

  • Ulrike Hoevelmann, MD · Profil, Neuss

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2025-04-12
Completion
2025-04-25

Countries

  • Germany

Study Locations

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Entities

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 NCT06758583 on ClinicalTrials.gov