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Semaglutide

Ozempic, Rybelsus, Wegovy

Quick Stats
Studies 78
Trials 100
Completed PHASE1 INTERVENTIONAL NCT05689099

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

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

Primary Outcomes

Measure: 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
TimeFrame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Description: Measured in hours\*nanomoles per liter (h\*nmol/L).
Measure: Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration
TimeFrame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Description: Measured in nanomoles per liter (nmol/L).

Trial Information

NCT ID

NCT05689099

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Novo Nordisk A/S

Last Updated

December 15, 2025