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

Sponsor
Novo Nordisk A/S
Study ID
NCT06642584
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers Type 2 Diabetes

Eligibility Criteria

Sex
MALE
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide B — DRUG
    Semaglutide B will be administered subcutaneously.
  • Semaglutide J — DRUG
    Semaglutide J will be administered as oral tablets.
  • Semaglutide L — DRUG
    Semaglutide L will be administered as oral tablets.
  • Semaglutide M — DRUG
    Semaglutide M will be administered as oral tablets.
  • Semaglutide N — DRUG
    Semaglutide N will be administered as oral tablets.

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Oct 2025
Primary completion
Jul 10, 2025
Completion
Aug 13, 2025

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve [ Time Frame: From 0 to 24 hours after dosing on Days 122 and 132. ]