GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide

A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector 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, Obesity / overweight

Key I/E criterion

•BMI 25-34.9

Primary endpoints

•AUC0-last,sema 0.5mg•Cmax,sema,0.5mg

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 IDNCT05232708

Org study IDNN9535-4885

Secondary ID2021-003216-25

Secondary IDU1111-1266-4076World Health Organization (WHO)

Timeline

Milestones

Study start2022-01-19actual

Study first posted2022-02-10actual

Primary completion2022-08-30actual

Study completion2022-08-30actual

Last update posted2024-01-26actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age20 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female

•Aged 20-55 years (both inclusive) at the time of signing informed consent

•Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive)

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method

•Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

•Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, 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 before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (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 or chemical substance abuse within 1 year before screening

–Positive drug of abuse test at screening

Endpoints (2)

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

2 endpoints

Primary/protocol endpoint

AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg

Time frame:0-840 hours after a single dose of s.c. semaglutide 0.5 mg

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of s.c. semaglutide 0.5 mg administration

Time frame:0-840 hours after a single dose of s.c. semaglutide 0.5 mg

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.