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

NCT06097390 | Completed Phase 1

• 2 other identifiers: NN9501-4924U1111-1289-1040
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

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).

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

Secondary Outcomes (3)

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

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

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

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

• t½,sema; the terminal half-life of semaglutide

  From 0 to 840 hours after dosing on day 90

Study Arms (2)

Sequence 1: Semaglutide J then Semaglutide K

EXPERIMENTAL

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

Drug: Semaglutide

Sequence 2: Semagultide K then Semaglutide J

EXPERIMENTAL

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

Drug: Semaglutide

Interventions

Semaglutide DRUG

Oral administration

Sequence 1: Semaglutide J then Semaglutide K; Sequence 2: Semagultide K then Semaglutide J

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

semaglutide

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 18, 2023
• First Posted: October 24, 2023
• Study Start: September 28, 2023
• Primary Completion: February 22, 2024
• Study Completion: March 27, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)