GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study to Compare Two Different Forms of Once-weekly Semaglutide in Two Different Injection Pens

A Trial to Demonstrate Bioequivalence Between the Semaglutide D Formulation for the DV3396 Pen-Injector and the Formulation for the PDS290 Pen-Injector Following Subcutaneous Administration of 2 mg Semaglutide

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

111

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 25-34.9

Primary endpoints

•AUC of semaglutide from time 0 until last quantifiable measurement after one•Maximum observed semaglutide concentration after one dose of s.c. semaglutide 2

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 IDNCT04238962

Org study IDNN9535-4601

Secondary ID2019-003477-25European Medicines Agency (EMA)

Secondary IDU1111-1239-1473World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-01-23actual

Study start2020-02-03actual

Primary completion2020-10-20actual

Study completion2020-10-20actual

Last update posted2020-11-20actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent.

•Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

•Body weight between 65.0 and 130.0 kg (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

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

•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 and acetylsalicylic acid (the two latter are not allowed within 24 hours before screening), within 14 days prior to the day of screening.

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

•Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than an average intake of 24 g alcohol daily for men and 12 g alcohol daily for women -12 g of alcohol equals about 300 mL of beer or lager, 100 mL of wine, or 25 mL spirits)

•Positive alcohol test at screening

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

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

•Positive drug of abuse test at screening

Endpoints (5)

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

5 endpoints

Primary/protocol endpoint

AUC0-last,sema,2mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period