> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-research-study-looking-at-the-comparability-of-2-different-0bc991b0-78bd-4e43-a8f6-9ab5cd7dacc1 > Record changed: 2026-10-13 # A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People NCT05227196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) Participants 546 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) Start date 2022-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Short title** A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Official title** A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Dates **Completion date** 2023-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **First posted** 2022-02-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Registry last updated** 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Primary completion date** 2023-06-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Start date** 2022-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Size and sites **Actual participants** 546 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Participants** 546 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Identifiers **Registry ID** NCT05227196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **ClinicalTrials.gov ID** NCT05227196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Outcomes ### Primary outcomes 1. AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS) Timeframe: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. h∙nmol/L 2. Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state Timeframe: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. nmol/L ### Secondary outcomes 1. tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state Timeframe: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. h 2. Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state Timeframe: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. nmol/L Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 64 Years **Healthy volunteers** Yes ### Inclusion criteria - Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 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 - 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). 1. As declared by the participant or reported in the medical records Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Sites - Altasciences Clinical LA, Inc.Cypress, United States - Altasciences Clinical Kansas, Inc.Overland Park, United States - Altasciences Company Inc.Montreal, Canada Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## References - PubMed 39708086 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39708086/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05227196) ## Related records ### Drugs (1) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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