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The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Sequence 1 | Experimental | Crossover arm |
|
| Group 1 Sequence 2 | Experimental | Crossover arm |
|
| Group 2 Sequence 1 | Experimental | Crossover arm |
|
| Group 2 Sequence 2 | Experimental | Crossover arm |
|
| Group 3 Sequence 1 | Experimental | Crossover arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide D Dose 1 | Drug | Tablet given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS) | h∙nmol/L | 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. |
| Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state | nmol/L | 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. |
| Measure | Description | Time Frame |
|---|---|---|
| tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state | h | 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. |
| Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state |
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Inclusion Criteria:
Exclusion Criteria:
HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening.
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).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (Dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical LA, Inc. | Cypress | California | 90630 | United States | ||
| Altasciences Clinical Kansas, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39708086 | Derived | 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. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Group 3 Sequence 2 |
| Experimental |
Crossover arm |
|
| Semaglutide D Dose 2 | Drug | Tablet given orally |
|
| Semaglutide D Dose 3 | Drug | Tablet given orally |
|
| Semaglutide Dose 4 | Drug | Tablet given orally |
|
| Semaglutide Dose 5 | Drug | Tablet given orally |
|
| Semaglutide Dose 6 | Drug | Tablet given orally |
|
nmol/L |
| 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. |
| Overland Park |
| Kansas |
| 66212 |
| United States |
| Altasciences Company Inc. | Montreal | Quebec | H3P 3P1 | Canada |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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