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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

Currently, no drugs are globally approved for the treatment of non-alcoholic steatohepatitis (NASH). First-line of treatment is lifestyle intervention to achieve weight loss. Combination treatment with multiple drugs may be more effective. This trial will assess the safety and efficacy of three doses of NNC0194-0499 (the study drug) in combination with semaglutide versus placebo in the treatment of NASH.

The purpose of this voluntary research study is to test if 2 combinations of medicines (1:NNC01940499 and semaglutide, 2: NNC0174-0833 and semaglutide) can reduce liver damage in patients with NASH. If you enroll in this study, you will undergo a series of testing. For treatment, you will be asked to inject yourself once a week for with the study medicine.

800

Jonathan Stine
Gloriany Rivas - at grivas@pennstatehealth.psu.edu or 717-531-0003, ext=320223
 

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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05016882
STUDY00017986
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Inclusion Criteria:
Aged ≥ 18 years at the time of signing informed consent
Evidence of NASH based on a liver biopsy
Stage 2, 3 or 4 of fibrosis
non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 4
Exclusion Criteria:
causes of chronic liver disease other than NAFLD
cirrhosis
Treatment with vitamin E
alcohol dependence
Digestive Systems & Liver Disease
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Hershey, PA ,