NCT05766709

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations

Investigation of Pharmacokinetics Following Administration of NNC0194-0499 and Semaglutide as Co-formulation Versus Separate Injections in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Novo Nordisk is developing a combination of 2 medicines (NNC0194-0499 and semaglutide) for the treatment of nonalcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used to treat type 2 diabetes and obesity. The study is being done to see how 2 medicines (NNC0194-0499 and semaglutide) are absorbed, transported, and eliminated from the body in a combination formulation. Participants will either get NNC0194-0499 and semaglutide in a combination formulation or the separate formulations. Which treatment participants get is decided by chance. The study will last for either 13 or 33 weeks. The duration is decided by chance.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	NNC0194-0499	NNC0194-0499 will be administered subcutaneously once weekly.
DRUG	Semaglutide	Semaglutide will be administered subcutaneously once weekly.
DRUG	NNC0194-0499/Semaglutide A (40/3.20 mg/mL)	NNC0194-0499/Semaglutide A (40/3.20 mg/mL) co-formulation product will be administered subcutaneously once weekly.
DRUG	NNC0194-0499/Semaglutide A (40/0.33mg/mL)	NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.

Timeline

• Start date: 2023-03-02
• Primary completion: 2024-01-05
• Completion: 2024-02-09
• First posted: 2023-03-13
• Last updated: 2024-02-29

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study