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

NCT06642584 | Completed Phase 1

• 2 other identifiers: NN9501-5006U1111-1304-9627
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (6)

Sequence 1: Semaglutide J then Semaglutide L

EXPERIMENTAL

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; Drug: Semaglutide J; Drug: Semaglutide L

Sequence 2: Semaglutide L then Semaglutide J

EXPERIMENTAL

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; Drug: Semaglutide J; Drug: Semaglutide L

Sequence 3: Semaglutide J then Semaglutide M

EXPERIMENTAL

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; Drug: Semaglutide J; Drug: Semaglutide M

Sequence 4: Semaglutide M then Semaglutide J

EXPERIMENTAL

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; Drug: Semaglutide J; Drug: Semaglutide M

Sequence 5: Semaglutide J then Semaglutide N

EXPERIMENTAL

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; Drug: Semaglutide J; Drug: Semaglutide N

Sequence 6: Semaglutide N then Semaglutide J

EXPERIMENTAL

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; Drug: Semaglutide J; Drug: Semaglutide N

Interventions

Semaglutide B DRUG

Semaglutide B will be administered subcutaneously.

Sequence 1: Semaglutide J then Semaglutide L; Sequence 2: Semaglutide L then Semaglutide J; Sequence 3: Semaglutide J then Semaglutide M; Sequence 4: Semaglutide M then Semaglutide J; Sequence 5: Semaglutide J then Semaglutide N; Sequence 6: Semaglutide N then Semaglutide J

Semaglutide J DRUG

Semaglutide J will be administered as oral tablets.

Sequence 1: Semaglutide J then Semaglutide L; Sequence 2: Semaglutide L then Semaglutide J; Sequence 3: Semaglutide J then Semaglutide M; Sequence 4: Semaglutide M then Semaglutide J; Sequence 5: Semaglutide J then Semaglutide N; Sequence 6: Semaglutide N then Semaglutide J

Semaglutide L DRUG

Semaglutide L will be administered as oral tablets.

Sequence 1: Semaglutide J then Semaglutide L; Sequence 2: Semaglutide L then Semaglutide J

Semaglutide M DRUG

Semaglutide M will be administered as oral tablets.

Sequence 3: Semaglutide J then Semaglutide M; Sequence 4: Semaglutide M then Semaglutide J

Semaglutide N DRUG

Semaglutide N will be administered as oral tablets.

Sequence 5: Semaglutide J then Semaglutide N; Sequence 6: Semaglutide N then Semaglutide J

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male.
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (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 (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

You may not qualify if:

• Known or suspected hypersensitivity to study interventions or related products.
• Any condition 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 prior to first dosing.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences

Montreal, Quebec, H3P 3P1, Canada

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: July 10, 2025
• Study Completion: August 13, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)