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

NCT05689099 · Completed

Last updated 2026-05-28

This clinical trial compares how two different formulations of semaglutide at a 0.5 mg dose are absorbed in the body, testing it in adults with type 2 diabetes and healthy participants.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 20 people

Who can join Ages 18–55 · all sexes Healthy volunteers accepted.

Timeline Started 2023-01 · est. completion 2023-05

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT05689099 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide B, 1.34 mg/mL Drug

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

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

Main thing measured	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
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2, Healthy Participants
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05689099 ↗