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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers (Diabetes Mellitus, Type 2)

Treatments

Drug: Semaglutide B, 1.34 mg/mL

Drug: Semaglutide D, 1.0 mg/mL

Study type

Interventional

Funder types

Industry

Identifiers

NCT05232708

2021-003216-25 (EudraCT Number)

U1111-1266-4076 (Other Identifier)

NN9535-4885

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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