GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

An Open-label, Randomized, Parallel-group, Single-center Trial to Compare Pharmacokinetics of Dapiglutide After a Single Subcutaneous Dose of the Drug Product Concentrations 10 mg/mL or 25 mg/mL in Participants With Overweight or Obesity

Lead sponsor

Zealand Pharma

Asset

Dapiglutide

Subcutaneous · GLP-1 / GLP-2 dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥27•HbA1c ≤6.5%

Primary endpoint

•Pharmacokinetics of a single dose administration of 7.5 mg dapiglutide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06758583

Org study IDZP7570-24026

Secondary ID2024-516901-21

Timeline

Milestones

Study start2024-12-23actual

Study first posted2025-01-06actual

Primary completion2025-04-12actual

Study completion2025-04-25actual

Last update posted2025-05-06actual

Assets

Investigational agents

Dapiglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Age between 18 and 64 years, both inclusive,

•BMI >= 27.0 kg/m^2

•HbA1c < 6.5 %.

Exclusion criteria

•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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

10 endpoints

Primary/protocol endpoint

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

Time frame:Trial Day 1 to 28

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Trial Day 1 to 28

Cmax

concentration, descriptive

Secondary/protocol endpoint