NCT05689099

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Semaglutide B, 1.34 mg/mL	Participants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
DRUG	Semaglutide B, 0.68 mg/mL	Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.

Timeline

• Start date: 2023-01-17
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2023-01-18
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study