NCT05016882|CompletedPhase 2FDA Drug

Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)

Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9500-4656U1111-1255-55512020-003566-39

Study Type

interventional

Target

698

Locations

24 countries

Sites

255

Timeline

RegisteredAug 2021

StartedAug 2021

CompletionMar 2025

Brief Summary

This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH). NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own. The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH. Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine. The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor. Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment. Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

698

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2021

Typical duration for phase_2

Geographic Reach

24 countries

255 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

First Submitted

Initial submission to the registry

August 18, 2021

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed

8 days until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2025

Completed

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

August 18, 2021

Last Update Submit

November 17, 2025

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

Improvement in liver fibrosis and no worsening of NASH (Yes/No)
Count of subjects Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale
From baseline (week 0) to week 52

Secondary Outcomes (24)

Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
From baseline (week 0) to week 52
Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
From baseline (week 0) to week 52
Change in histology-assessed liver collagen proportionate area
From baseline (week 0) to week 52
Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
From baseline (week 0) to week 52
Improvement in liver fibrosis (Yes/No)
From baseline (week 0) to week 52
+19 more secondary outcomes