A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose

NCT ID: NCT05689099

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2023-05-30

Brief Summary

In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug Administration (FDA), has approved semaglutide in prefilled pen-injector form. Currently, the drug concentration of 1.34 mg/ml can be prescribed in some countries including U.S. The objective of the study is to compare the amount of investigational drug taken up in the body for the 2 drug concentrations. Participants will be divided by chance into 2 groups. Group A will receive a single dose of 0.5 mg semaglutide of the drug concentration 1.34 mg/mL in the first study period; and will receive a single dose of 0.5 mg semaglutide of the drug concentration 0.68 mg/mL in the second study period. Participants assigned to group B will receive the two drug concentrations in the reverse order. Participants will get 1 subcutaneous injection on Day 1 of each of the two study periods. The two injections are separated by 7-11 weeks. The study will last up to approximately 87 to 141 days for each participant. This includes a screening period (up to 4 weeks), study period 1 (5 weeks), washout period (2-6 weeks), and study period 2 (5 weeks). At some periods during the study, participant should not get vaccinations. Participant should agree on timing of vaccination with study doctor. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Conditions

Diabetes Mellitus, Type 2; Healthy Participants

Study Design

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

Study Groups

Sequence A

Participants will be administered a single subcutaneous (s.c.) dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 2.

Group Type: EXPERIMENTAL

Semaglutide B, 1.34 mg/mL

Intervention Type: DRUG

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

Semaglutide B, 0.68 mg/mL

Intervention Type: DRUG

Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.

Sequence B

Participants will be administered a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 2.

Group Type: EXPERIMENTAL

Semaglutide B, 1.34 mg/mL

Intervention Type: DRUG

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

Semaglutide B, 0.68 mg/mL

Intervention Type: DRUG

Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.

Interventions

Semaglutide B, 1.34 mg/mL

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

Intervention Type: DRUG

Semaglutide B, 0.68 mg/mL

Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female
• Aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 20.0 and 29.9 kilograms 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 highly effective 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, ibuprofen and acetylsalicylic acid, within 14 days prior to the day of screening
• Abuse or intake of alcohol, defined as any of the below:

1. 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)

2. Positive alcohol test at screening

• Abuse or intake of drugs, defined as any of the below:

1. Known or suspected drug or chemical substance abuse within 1 year before screening

2. Positive drug of abuse test at screening

• Minimum Eligible Age: 18 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

Altasciences Clinical LA, Inc.

Cypress, California, United States

Countries

United States

Other Identifiers

U1111-1280-1368

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-7560

Identifier Type: -

Identifier Source: org_study_id