GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes

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 18.5-30•Healthy volunteers

Primary endpoints

•Area under the plasma semaglutide concentration curve•Cmax, the maximum plasma semaglutide concentration

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 IDNCT01766245

Org study IDNN9535-4010

Secondary ID2012-002212-20

Secondary IDU1111-1130-3931WHO

Timeline

Milestones

Study first posted2013-01-11estimated

Last update posted2014-06-25estimated

Study start2012-12 (month precision)

Primary completion2013-05actual (month precision)

Study completion2013-05actual (month precision)

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

•Healthy subjects

•Body mass index (BMI) of 18.5-30 kg/m^2 (both incl.)

Exclusion criteria

•History of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders

•Use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide

•Smoking, drug or alcohol abuse

•Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide

Endpoints (7)

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

7 endpoints

Primary/protocol endpoint

Area under the plasma semaglutide concentration curve

Time frame:0-4 weeks after a single dose s.c. semaglutide administration

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax, the maximum plasma semaglutide concentration

Time frame:20-40 hours after a single dose s.c. semaglutide administration

Cmax

concentration, descriptive

Secondary/protocol endpoint

The area under the plasma semaglutide concentration curve

Time frame:From time 0 to infinity after a single dose s.c. semaglutide administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

tmax, time to Cmax of semaglutide

Time frame:20-40 hours

Tmax

concentration, descriptive

Secondary/protocol endpoint

t½, terminal elimination half-life of semaglutide

Time frame:140-200 hours

Half-life

descriptive

Secondary/protocol endpoint

Incidence of adverse events (AEs)

Time frame:From first dosing to follow-up (5-7 weeks after the second dosing)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Hypoglycaemic episodes

Time frame:From first dosing to follow-up (5-7 weeks after the second dosing)

event count, event

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.