A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
NCT ID: NCT05227196
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
546 participants
INTERVENTIONAL
2022-02-04
2023-08-08
Brief Summary
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The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.
The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1 Sequence 1
Crossover arm
Semaglutide D Dose 1
Tablet given orally
Semaglutide D Dose 2
Tablet given orally
Semaglutide D Dose 3
Tablet given orally
Semaglutide Dose 6
Tablet given orally
Group 1 Sequence 2
Crossover arm
Semaglutide D Dose 3
Tablet given orally
Semaglutide Dose 4
Tablet given orally
Semaglutide Dose 5
Tablet given orally
Semaglutide Dose 6
Tablet given orally
Group 2 Sequence 1
Crossover arm
Semaglutide D Dose 1
Tablet given orally
Semaglutide D Dose 2
Tablet given orally
Semaglutide Dose 4
Tablet given orally
Semaglutide Dose 5
Tablet given orally
Group 2 Sequence 2
Crossover arm
Semaglutide D Dose 1
Tablet given orally
Semaglutide D Dose 2
Tablet given orally
Semaglutide Dose 4
Tablet given orally
Semaglutide Dose 5
Tablet given orally
Group 3 Sequence 1
Crossover arm
Semaglutide D Dose 1
Tablet given orally
Semaglutide Dose 4
Tablet given orally
Group 3 Sequence 2
Crossover arm
Semaglutide D Dose 1
Tablet given orally
Semaglutide Dose 4
Tablet given orally
Interventions
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Semaglutide D Dose 1
Tablet given orally
Semaglutide D Dose 2
Tablet given orally
Semaglutide D Dose 3
Tablet given orally
Semaglutide Dose 4
Tablet given orally
Semaglutide Dose 5
Tablet given orally
Semaglutide Dose 6
Tablet given orally
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of tobacco and nicotine products, defined as any of the below:
* Smoking more than 5 cigarettes or the equivalent per day
* Not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
* History(a) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant(a).
* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).
1. As declared by the participant or reported in the medical records
18 Years
64 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (Dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Altasciences Clinical LA, Inc.
Cypress, California, United States
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States
Altasciences Company Inc.
Montreal, Quebec, Canada
Countries
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References
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Nielsen MS, Brondsted L, Kankam M, Morelli G, Nguyen D, Skjoth TV, Patted UR, van Hout M. A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants. Diabetes Ther. 2025 Feb;16(2):269-287. doi: 10.1007/s13300-024-01674-8. Epub 2024 Dec 21.
Other Identifiers
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NN9924-4799
Identifier Type: -
Identifier Source: org_study_id
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