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

• Status: Recruiting
• Trial end date: 2022-06-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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