NCT06758583

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

December 23, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

December 9, 2024

Last Update Submit

May 1, 2025

Conditions

Overweight and Obesity

Keywords

GLP-1R/GLP-2RAoverweightobesityweight management

Outcome Measures

Primary Outcomes (2)

  • To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide

    Area under the dapiglutide plasma concentration-time curve from time zero to infinity after a single 7.5 mg dose of dapiglutide (AUC0-inf).

    Trial Day 1 to 28

  • To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide

    Maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Cmax)

    Trial Day 1 to 28

Secondary Outcomes (8)

  • To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide

    Day 1 to 28

  • To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide

    Day 1 to 28

  • To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide

    Day 1 to 28

  • To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide

    Day 1 to 28

  • To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide

    Day 1 to 28

  • +3 more secondary outcomes

Study Arms (2)

Dapiglutide 10 mg/mL

EXPERIMENTAL

Single dose, s.c. administration

Drug: Dapiglutide 7.5 mg

Dapiglutide 25 mg/mL

EXPERIMENTAL

Single dose, s.c. administration

Drug: Dapiglutide 7.5 mg

Interventions

Dapiglutide 7.5 mgDRUG

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

Dapiglutide 10 mg/mLDapiglutide 25 mg/mL

Eligibility Criteria

Age18 Years - 64 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing are not eligible to participate
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 64 years, both inclusive,
  • BMI \>= 27.0 kg/m\^2
  • HbA1c \< 6.5 %.

You may not qualify if:

  • Any history or presence of a disorder or a disease, which, in the investigator's opinion, might jeopardize participant's safety, evaluation of results or compliance with the protocol, treatment with dapiglutide (any exposure) or any other drugs, including dual and tri agonists, involving a GLP-1 RA or GLP-2 RA within 180 days prior to screening.
  • Any medication (prescription and non-prescription drugs) with the exception of stable treatment with antihypertensive and lipid-lowering drugs as well as thyroid replacement therapy.
  • Female participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ulrike Hoevelmann, MD

    Profil, Neuss

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

January 6, 2025

Study Start

December 23, 2024

Primary Completion

April 12, 2025

Study Completion

April 25, 2025

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The data collection and handling of clinical trial data at the trial site has been designed to limit the possibility of identifying trial subjects from their data. To this end, pseudonymised data will be used wherever possible and the collection of demographic information that could be used for re-identification of subjects will be restricted to the extent necessary for the conduct of this trial.

Locations

DE(1)