GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02920385

CompletedPhase 1

A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29.9•Healthy volunteers

Primary endpoints

•Baseline-corrected AUC of total T4 from 0•AUC of semaglutide during a dosing interval (0-24 hours) at steady state

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 IDNCT02920385

Org study IDNN9924-4279

Secondary ID2015-005558-36

Secondary IDU1111-1177-2807WHO

Timeline

Milestones

Study first posted2016-09-30estimated

Study start2016-10-10actual

Primary completion2017-04-26actual

Study completion2017-06-16actual

Last update posted2017-12-14actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female aged 18-50 years (both inclusive) at the time of signing informed consent

•Body mass index (BMI) 20.0 to 29.9 kg/m^2 (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

•Smoker (defined as a subject who is smoking at least 1 cigarette or the equivalent per day)

•Unable or unwilling to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods

•Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening

•History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

•History (as declared by the subject) or presence of clinical or non-clinical thyroid disease, including thyroid palpation abnormalities, levels of T3 or T4 (total and free) or TSH outside reference limits, or presence of thyroid antibodies (Thyroid Stimulating Hormone Receptor Antibody, Thyroperoxidase Antibody or Thyroid Antithyroglobulin Antibodies)

Endpoints (6)

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

6 endpoints

Primary/protocol endpoint

Baseline-corrected area under the total T4 serum concentration-time curve from 0 to 48 hours after a single dose of levothyroxine

Time frame:On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the semaglutide plasma concentration-time curve during a dosing interval (0-24 hours) at steady state

Time frame:On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Baseline-corrected maximum observed total T4 serum concentration from 0 to 48 hours after a single dose of levothyroxine

Time frame:On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration during a dosing interval from (0-24 hours) at steady state

Time frame:On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the SNAC plasma concentration-time curve during a dosing interval (0-24 hours) at steady state

Time frame:On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed SNAC plasma concentration during a dosing interval (0-24 hours) at steady state

Time frame:On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

Plasma concentration (steady state)

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.