A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide
- Conditions
- Healthy Volunteers (Diabetes Mellitus, Type 2)
- Interventions
- Registration Number
- NCT05232708
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Male or female
- Aged 20-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive)
-
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
-
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 medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening
-
Abuse or intake of alcohol, defined as any of the below:
- Known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (mL) of beer or lager, 100 mL of wine, or 25 mL spirits).
- Positive alcohol test at screening.
-
Abuse or intake of drugs, defined as any of the below:
- Known or suspected drug or chemical substance abuse within 1 year before screening
- Positive drug of abuse test at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL Semaglutide B, 1.34 mg/mL - Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL Semaglutide D, 1.0 mg/mL - Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL Semaglutide D, 1.0 mg/mL - Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL Semaglutide B, 1.34 mg/mL -
- Primary Outcome Measures
Name Time Method 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 0-840 hours after a single dose of s.c. semaglutide 0.5 mg Measured in h\*nmol/L
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of s.c. semaglutide 0.5 mg administration 0-840 hours after a single dose of s.c. semaglutide 0.5 mg Measured in nmol/L
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Parexel CPRU, Level 7
🇬🇧Harrow, Middlesex, United Kingdom