NNC0194-0499 + Semaglutide for Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if combining two medicines, NNC0194-0499 and semaglutide, can reduce liver damage in people with non-alcoholic steatohepatitis (NASH). Semaglutide, already used for diabetes and weight loss, and NNC0194-0499 work differently but may be more effective together. Another combination being tested includes semaglutide and NNC0174-0833. Participants will receive regular injections and undergo liver biopsies to measure the treatment's effectiveness.
Who Is on the Research Team?
Clinical Transparency (dept. 1452)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
Adults with a certain liver condition called NASH and evidence of liver scarring (fibrosis stages 2-4) can join this study. They must have had a recent biopsy confirming the disease. Pregnant women or those planning pregnancy, heavy drinkers, and people on unstable doses of certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly injections of either two active drugs, one active drug and one placebo, or two placebo injections for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NNC0174 0833 10 mg/mL
- NNC0174 0833 placebo
- NNC0194 0499 50 mg/mL
- Placebo (NNC0194-0499)
- Semaglutide
- Semaglutide placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen