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

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210294

Enrollment

Registered

2021-09-05

Start date

2021-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-alcoholic steatohepatitis

Interventions

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 -s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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.

Exclusion criteria

Exclusion criteria: -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)).

Design outcomes

Primary

Measure	Time frame
Improvement in liver fibrosis and no worsening of NASH	—

Secondary

Measure	Time frame
Resolution of steatohepatitis and no worsening of liver fibrosis Number of treatment emergent adverse events	—

Countries

Australia, Belgium, Bulgaria, Canada, Denmark, France, Germany, Greece, India, Italy, Japan, Korea, Malaysia, Netherlands, Poland, Russian Fed., Singapore, Spain, United Kingdom, United States

Contacts

Public ContactKahori Okada

Novo Nordisk Pharma Ltd.

JPHC_clinical_trials@novonordisk.com+81-362661000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026