> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-research-study-looking-at-new-protein-based-tablets-in-9277f598-b3a7-4389-b9b8-bc19c62da431 > Record changed: 2026-11-04 # A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III NCT06097390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) Participants 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) Start date 2023-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Title and summary **Summary** In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. The study will enroll healthy male participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Short title** A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Official title** A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Dates **Completion date** 2024-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **First posted** 2023-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Registry last updated** 2025-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Primary completion date** 2024-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Start date** 2023-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Size and sites **Actual participants** 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Participants** 121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Identifiers **Registry ID** NCT06097390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **ClinicalTrials.gov ID** NCT06097390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Outcomes ### Primary outcomes 1. Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve Timeframe: From 0 to 24 hours after dosing on day 80 and 90 Measured in hour\\\*nanomoles per liter (h\\\*nmol/L). ### Secondary outcomes 1. Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration Timeframe: From 0 to 24 hours after dosing on day 80 and 90 Measured in nanomoles per liter (nmol/L). 2. Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration Timeframe: From 0 to 24 hours after dosing on day 80 and 90 Measured in hours. 3. t½,sema; the terminal half-life of semaglutide Timeframe: From 0 to 840 hours after dosing on day 90 Measured in hours. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 64 Years **Healthy volunteers** Yes Key inclusion criteria: - Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m^2) (both inclusive) at screening. - 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. Key exclusion criteria: - Known or suspected hypersensitivity to study intervention(s) or related products. - Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. - Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## Sites - Altasciences Clinical Company, IncMontreal, Canada Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## References ### Other registry identifiers - U1111-1289-1040 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06097390) ## 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) ### 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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