GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

A Single-centre, Parallel-group, Randomised, Double-blind, Placebocontrolled, Multiple-dose Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

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 20-25•Male•Healthy volunteers

Primary endpoint

•AUC of semaglutide

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 IDNCT02146079

Org study IDNN9535-3634

Secondary IDJapicCTI-142550JAPIC

Secondary IDU1111-1147-6660WHO

Timeline

Milestones

Study start2014-05-21actual

Study first posted2014-05-23estimated

Primary completion2014-10-20actual

Study completion2014-10-20actual

Last update posted2018-04-18actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Healthy male Japanese and Caucasian subjects

•Age between 20 and 55 years (both inclusive) at the time of signing informed consent

•Body weight of equal to or above 54.0 kg

•Body mass index (BMI) between 20.0 and 25.0 kg/m^2 (both inclusive)

•Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%

•For Japanese subjects only: both parents Japanese

•For Caucasian subjects only: both parents Caucasian

Exclusion criteria

•Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)

•History of chronic pancreatitis or idiopathic acute pancreatitis

•Calcitonin above or equal to 50 ng/L

•History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits

•Smoking of more than 5 cigarettes (including nicotine substitute products) or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure

•Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (randomisation), non-prescription drugs within 1 week prior to Visit 2 (randomisation). The use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted

Endpoints (4)

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.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight from baseline to the end of treatment

Time frame:Day 1 of Visit 2 (2-21 days after Visit 1), Day 92

Body weight, absolute change (kg)

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Area under the plasma semaglutide concentration-time curve

Time frame:During a dosing interval (0-168 hours) at steady state

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed plasma semaglutide concentration at steady state

Time frame:0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs) from baseline to follow-up

Time frame:From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)

Treatment-emergent AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.
Advances in therapy2018 Apr (month)PMID29536338doi:10.1007/s12325-018-0677-1via CT.gov reference + pubmed nct search

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.