GLPwatch

A Research Study Looking at New Protein-based Tablets in Healthy Male Participants

NCT05129891 · Completed

Last updated 2026-05-28

This study is testing new protein-based tablets in healthy men and men with high cholesterol or type 2 diabetes to see how the tablets are absorbed in the body after 10 days of use.

Status Completed The study has finished.
Phase Phase 1 Checks safety and dosing in a small group.
Type Interventional (clinical trial)
Design Randomized, open-label (no blinding) treatment study
Participants 384 people
Who can join Ages 18–55 · male only Healthy volunteers accepted.
Timeline Started 2021-11 · est. completion 2023-05
Where 2 sites · Canada, Germany

What this study is testing ClinicalTrials.gov NCT05129891 ↗

Description as written by the study sponsor.

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)

Treatments tested

Main thing measuredAUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
SponsorNovo Nordisk A/S
Conditions studiedHealthy Volunteers, High Blood Cholesterol Levels, Type 2 Diabetes
GLP-1 drugs —

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05129891 ↗