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CompletedPhase 1

Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes.

Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

2

Recruiting sites

-

Actual enrollment

55

Study population

Gastrointestinal (gastroparesis / short bowel / pancreatitis), Type 2 diabetes

Eligibility highlights

•BMI 18.5-39.9

Primary endpoint

•AUC of semaglutide

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02877355
Org study IDNN9924-4267
Secondary ID2015-004534-10
Secondary IDU1111-1175-5246WHO

Timeline

Milestones

Study start2016-08-22actual
Study first posted2016-08-24estimated
Primary completion2017-11-24actual
Study completion2017-11-24actual
Last update posted2019-04-29actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Gastrointestinal (gastroparesis / short bowel / pancreatitis)Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent
•Body mass index (BMI) between 18.5-39.9 kg/m^2 (both inclusive)
•Subjects diagnosed clinically with type 2 diabetes mellitus for at least 180 days prior to the first screening visit
•For subjects with upper gastrointestinal (GI) disease: Diagnosed with chronic gastritis and/or gastroesophageal reflux disease (GERD) at screening

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measures as required by local regulation or practice). (Highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner)
•History of pancreatitis (acute or chronic)
•History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
•Unable or unwilling to refrain from smoking during the in-patient periods
•Any blood draw in excess of 50 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within 90 days of the first screening visit

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.

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Area under the semaglutide plasma concentration-time curve

Time frame:From 0 to 24 hours after the 10th dosing

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration

Time frame:From 0 to 24 hours after the 10th dosing

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the SNAC plasma concentration-time curve

Time frame:During a dosing interval (0 to 24 hours) at steady state

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed SNAC plasma concentration

Time frame:During a dosing interval (0 to 24 hours) at steady state

Plasma concentration (steady state)

concentration, descriptive

Publications (2)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 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 6, 2026 snapshot.