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

A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants

This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers Type 2 Diabetes
• Intervention / Treatment: Drug: Semaglutide B; Drug: Semaglutide J; Drug: Semaglutide L; Drug: Semaglutide M; Drug: Semaglutide N

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3P 3P1
      • Altasciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male.
2. Age 18-64 years (both inclusive) at the time of signing the informed consent.
3. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
4. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

1. Known or suspected hypersensitivity to study interventions or related products.
2. Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. 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 prior to first dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: Semaglutide J then Semaglutide L; Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2.	Drug: Semaglutide B; Semaglutide B will be administered subcutaneously.; Drug: Semaglutide J; Semaglutide J will be administered as oral tablets.; Drug: Semaglutide L; Semaglutide L will be administered as oral tablets.
Experimental: Sequence 2: Semaglutide L then Semaglutide J; Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2.	Drug: Semaglutide B; Semaglutide B will be administered subcutaneously.; Drug: Semaglutide J; Semaglutide J will be administered as oral tablets.; Drug: Semaglutide L; Semaglutide L will be administered as oral tablets.
Experimental: Sequence 3: Semaglutide J then Semaglutide M; Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2.	Drug: Semaglutide B; Semaglutide B will be administered subcutaneously.; Drug: Semaglutide J; Semaglutide J will be administered as oral tablets.; Drug: Semaglutide M; Semaglutide M will be administered as oral tablets.
Experimental: Sequence 4: Semaglutide M then Semaglutide J; Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2.	Drug: Semaglutide B; Semaglutide B will be administered subcutaneously.; Drug: Semaglutide J; Semaglutide J will be administered as oral tablets.; Drug: Semaglutide M; Semaglutide M will be administered as oral tablets.
Experimental: Sequence 5: Semaglutide J then Semaglutide N; Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2.	Drug: Semaglutide B; Semaglutide B will be administered subcutaneously.; Drug: Semaglutide J; Semaglutide J will be administered as oral tablets.; Drug: Semaglutide N; Semaglutide N will be administered as oral tablets.
Experimental: Sequence 6: Semaglutide N then Semaglutide J; Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2.	Drug: Semaglutide B; Semaglutide B will be administered subcutaneously.; Drug: Semaglutide J; Semaglutide J will be administered as oral tablets.; Drug: Semaglutide N; Semaglutide N will be administered as oral tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve	Measured in hours nanomoles per liter (h * nmol/L).	From 0 to 24 hours after dosing on Days 122 and 132.
Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration	Measured in nanomoles per liter(nmol/L).	From 0 to 24 hours after dosing on Days 122 and 132.
Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration	Measured in hours.	From 0 to 24 hours after dosing on Days 122 and 132.
t½,sema; the terminal half-life of semaglutide	Measured in hours.	From 0 to 840 hours after dosing on Day 132.

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 13, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; Semaglutide
• Other Study ID Numbers: NN9501-5006; U1111-1304-9627 (Other Identifier: World Health Organisation (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No