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CompletedNCT06097390Updated Jul 17, 2025

A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III

A Phase 1 interventional study of Semaglutide in Healthy Participants, sponsored by Novo Nordisk A/S. Completed at 1 site in Canada. Open to male participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-17.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    Sequence 1: Semaglutide J then Semaglutide K

    Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2.

    Drug: Semaglutide

  • Experimental
    Sequence 2: Semagultide K then Semaglutide J

    Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2.

    Drug: Semaglutide

Interventions

  • DrugSemaglutide

    Oral administration

06

What researchers measure

Primary outcomes

  1. Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve

    Measured in hour\*nanomoles per liter (h\*nmol/L).

    Time frame: From 0 to 24 hours after dosing on day 80 and 90

Secondary outcomes

  1. Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration

    Measured in nanomoles per liter (nmol/L).

    Time frame: From 0 to 24 hours after dosing on day 80 and 90

  2. Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration

    Measured in hours.

    Time frame: From 0 to 24 hours after dosing on day 80 and 90

  3. t½,sema; the terminal half-life of semaglutide

    Measured in hours.

    Time frame: From 0 to 840 hours after dosing on day 90

07

Study locations

1 site
  • Altasciences Clinical Company, Inc
    Montreal, Quebec H3P 3P1, Canada
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06097390
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 24, 2023
Start date
Sep 28, 2023
Primary completion
Feb 22, 2024
Completion
Mar 27, 2024
Last update
Jul 17, 2025

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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