GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device and the Formulation for the PDS290 Semaglutide Pen-injector

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29.9•Healthy volunteers

Primary endpoints

•AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve•Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose

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 IDNCT03598621

Org study IDNN9535-4387

Secondary ID2017-003437-29European Medicines Agency (EudraCT)

Secondary IDU1111-1200-8075World Health Organization (WHO)

Timeline

Milestones

Study start2018-07-23actual

Study first posted2018-07-26actual

Primary completion2019-01-17actual

Study completion2019-01-17actual

Last update posted2020-01-09actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.

•Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).

•Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

•Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

•Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, within 14 days prior to the day of screening.

•Abuse or intake of alcohol, defined as any of the below:

a)Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than 24 g alcohol daily for men and 12 g alcohol daily for women.

b)Positive alcohol test at screening.

•Abuse or intake of drugs, defined as any of the below:

a)Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening.

b)Positive drug of abuse test at screening.

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.

Endpoints (9)

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

9 endpoints

Primary/protocol endpoint

AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration