> 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-1640c61e-abdc-4da3-91bc-10a6a33f453f > Record changed: 2026-10-13 # A Research Study Looking at New Protein-based Tablets in Healthy Male Participants NCT05129891 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) Participants 384 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) Start date 2021-11-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Title and summary **Summary** In this study, four new tablet versions of two compounds will be investigated. The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance. Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days. The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Short title** A Research Study Looking at New Protein-based Tablets in Healthy Male Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Official title** A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Dates **Completion date** 2023-05-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **First posted** 2021-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Registry last updated** 2024-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Primary completion date** 2023-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Start date** 2021-11-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Size and sites **Actual participants** 384 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Participants** 384 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Identifiers **Registry ID** NCT05129891 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **ClinicalTrials.gov ID** NCT05129891 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Outcomes ### Primary outcomes 1. AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose Timeframe: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration h \\\* nmol/L ### Secondary outcomes 1. Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose Timeframe: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration nmol/L 2. tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API Timeframe: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration hours Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria - Male. - Aged 18-55 years (both inclusive) at the time of signing informed consent. - Body mass index between 20.0 and 29.9 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 - Known or suspected hypersensitivity to study interventions or related products. - Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening. - Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol. - Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator. - History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## Sites - Altasciences Company Inc.Montreal, Canada - Parexel International GmbHBerlin, Germany Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## References ### Other registry identifiers (2) - 2021-001452-34 - U1111-1266-0672 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05129891) ## 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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