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CompletedPhase 1

Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

113

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 20-29.9HbA1c ≤6.5%Healthy volunteers

Primary endpoint

AUC of semaglutides

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 IDNCT02557620
Org study IDNN9535-4215
Secondary ID2014-005171-84
Secondary IDU1111-1164-2741WHO

Timeline

Milestones

Study first posted2015-09-23estimated
Last update posted2017-01-04estimated
Study start2015-09 (month precision)
Primary completion2016-04actual (month precision)
Study completion2016-04actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator
Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)
HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion criteria

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)
Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
History of pancreatitis (acute or chronic)
Screening calcitonin equal or above 50 ng/L
Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

Endpoints (5)

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

5 endpoints
Primary/protocol endpoint

Area under the semaglutide concentration-time curves

Time frame:At steady-state from 0 to168 hours after dosing on day 78

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration

Time frame:At steady-state derived from the concentration-time curves, within 168 hours from day 78

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From baseline (day 1, post-dose) to last follow-up visit (day 120)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the the single dose concentration-time curve

Time frame:From 0 to 300 min after administration of paracetamol (1.5 g) at day 51

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under the the single dose concentration-time curve

Time frame:From 0 to 300 min after administration of paracetamol (1.5 g) at day 79

AUC₀–∞

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.