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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Study to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.34 mg/mL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05689099
• Other study ID #: NN9535-7560
• Secondary ID: U1111-1280-1368
• Status: Completed
• Phase: Phase 1
• Start date: January 17, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Healthy Participants

Intervention

Drug:
• Semaglutide B, 1.34 mg/mL
Participants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
• Semaglutide B, 0.68 mg/mL
Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-last,sema 0.5mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after single dose of subcutaneous semaglutide 0.5 mg	Measured in hours*nanomoles per liter (h*nmol/L).	0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Primary	Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration	Measured in nanomoles per liter (nmol/L).	0-840 hours after a single dose of s.c. semaglutide 0.5 mg