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

NCT ID: NCT05232708

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2022-08-30

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.

Conditions

Healthy Volunteers (Diabetes Mellitus, Type 2)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL

Group Type: EXPERIMENTAL

Semaglutide B, 1.34 mg/mL

Intervention Type: DRUG

Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

Semaglutide D, 1.0 mg/mL

Intervention Type: DRUG

Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.

Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL

Group Type: EXPERIMENTAL

Semaglutide D, 1.0 mg/mL

Intervention Type: DRUG

Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.

Semaglutide B, 1.34 mg/mL

Intervention Type: DRUG

Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

Interventions

Semaglutide B, 1.34 mg/mL

Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

Intervention Type: DRUG

Semaglutide D, 1.0 mg/mL

Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.

Intervention Type: DRUG

Semaglutide D, 1.0 mg/mL

Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.

Intervention Type: DRUG

Semaglutide B, 1.34 mg/mL

Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Parexel CPRU, Level 7

Harrow, Middlesex, United Kingdom

Countries

United Kingdom

Other Identifiers

2021-003216-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1266-4076

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4885

Identifier Type: -

Identifier Source: org_study_id