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Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial(NN9500-4656)

Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial

Okada Kahori

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

JPHC_clinical_trials@novonordisk.com

Okada Kahori

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

+81-362661000

JPHC_clinical_trials@novonordisk.com

Complete

Sept. 01, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

-Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy.
-Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.
- Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) =>4 for subjects with F2/F3 or >=3 for subjects with F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.

-Documented causes of chronic liver disease other than NAFLD.
-Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at V2A.
-Presence or history of gastro-oesophageal varices >=grade 2 at V2A. For subjects with F4, an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2A must be available at V2A.
-Known or suspected excessive consumption of alcohol (> 20 g/day for women or > 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).

Both

non-alcoholic steatohepatitis

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections for 52 weeks.
-NNC0194-0499 or placebo
-semaglutide or placebo
-NNC0174-0833 or placebo

Improvement in liver fibrosis and no worsening of NASH

Resolution of steatohepatitis and no worsening of liver fibrosis
Number of treatment emergent adverse events

+81-3-5773-5570

June. 18, 2021

Yes

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com URL: http://novonordisk-trials.com

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