GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects

A Randomised, Single Centre, Double-blind, Incomplete Block Trial to Test for Equivalence Between Subcutaneous Injections of the GLP-1 Analogue NN9535 in 1 mg/ml, 3 mg/ml and 10 mg/ml Concentrations in Healthy Male Subject

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-27•Male

Primary endpoint

•AUC0-8 (NN9535), the AUC of NN9535 plasma- in the interval 0-8 after

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 IDNCT00813020

Org study IDNN9535-3679

Secondary ID2008-004990-17

Timeline

Milestones

Study first posted2008-12-22estimated

Last update posted2015-02-23estimated

Study start2009-01 (month precision)

Primary completion2009-04actual (month precision)

Study completion2009-04actual (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator

•Body weight between 80 kg and 110 kg (both inclusive)

•Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive

•Fasting plasma glucose max 108 mg/dl (6.0 mmol/l)

Exclusion criteria

•Known or suspected allergy to trial product(s) or related products

•Previous participation in this trial (randomisation)

•The receipt of any investigational medicinal product within 3 months prior to this trial

•Subjects who have had a clinically relevant illness within 4 weeks of dosing

•History of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders

•Regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period

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

AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration

Time frame:a 28 day time period

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax of the plasma NN9535 curve

Time frame:a 28 day time period

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.