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

NCT05766709 · Completed

Last updated 2026-05-28

This study compares how two diabetes medications, NNC0194-0499 and semaglutide, are absorbed into the bloodstream when taken together versus separately in people with non-alcoholic steatohepatitis.

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 53 people

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

Timeline Started 2023-03 · est. completion 2024-02

Where 1 site · Canada

What this study is testing ClinicalTrials.gov NCT05766709 ↗

Description as written by the study sponsor.

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.

Treatments tested

NNC0194-0499 Drug

NNC0194-0499 will be administered subcutaneously once weekly.
Semaglutide Drug

Semaglutide will be administered subcutaneously once weekly.
NNC0194-0499/Semaglutide A (40/3.20 mg/mL) Drug

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

NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.

Main thing measured	AUC 0-168 hour (h), 0499, steady state (SS): Area under the NNC0194-0499 concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide
Sponsor	Novo Nordisk A/S
Conditions studied	Non-alcoholic Steatohepatitis
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05766709 ↗