GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens

A Trial to Demonstrate Bioequivalence Between Semaglutide D Formulations 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 criteria

•BMI 25-34.9•Healthy volunteers

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 1

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 IDNCT04152915

Org study IDNN9535-4588

Secondary ID2019-002588-92European Medicines Agency (EudraCT)

Secondary IDU1111-1235-3506World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-11-05actual

Study start2019-11-25actual

Primary completion2020-05-25actual

Study completion2020-05-25actual

Last update posted2021-11-10actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

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

•Body mass index between 25.0 and 34.9 kg/m^2 (both inclusive) and

•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, except routine vitamins, topical medications, 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)

•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 (8)

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

8 endpoints

Primary/protocol endpoint

AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period

Time frame:0-840 hours after one dose of s.c. semaglutide 1 mg

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax,sema,1mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period

Time frame:0-840 hours after one dose of s.c. semaglutide 1 mg

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h,sema,0.25mg,SS: Area under the semaglutide concentration time curve from time 0 until 168 hours at steady state after the last dose of s.c. semaglutide 0.25 mg administration

Time frame:0-168 hours after the last dose of s.c. semaglutide 0.25 mg

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,0.25mg,SS: Maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration

Time frame:0-168 hours after the last dose of s.c. semaglutide 0.25 mg

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-∞,sema,1mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period

Time frame:0-840 hours after one dose of s.c. semaglutide 1 mg

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

tmax,sema,1mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period

Time frame:0-840 hours after one dose of s.c. semaglutide 1 mg

Tmax

descriptive

Secondary/protocol endpoint

tmax,sema,0.25mg,SS: Time of maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration

Time frame:0-168 hours after the last dose of s.c. semaglutide 0.25 mg

Tmax

descriptive

Secondary/protocol endpoint

t½,sema,1mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period

Time frame:0-840 hours after one dose of s.c. semaglutide 1 mg

Half-life

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.