A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide

Sponsor
Novo Nordisk A/S
Study ID
NCT05232708
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers (Diabetes Mellitus, Type 2)

Eligibility Criteria

Sex
ALL
Age
20 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.

Key Dates

Start date
Jan 19, 2022
Status verified
Jan 2024
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022

Study Design

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

Arms

  • Experimental: Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL
  • Experimental: Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL

Primary Outcome Measure

AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg [ Time Frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg ]