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

Associated condition: NASH

Status: Currently enrolling

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.

Primary objectives: 

Improvement in liver fibrosis and no worsening of NASH (Yes/No) [ Time Frame: From baseline (week 0) to week 52 ]

  • Count of subjects Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale

Estimated length of study:  It is estimated that the study be fully completed by September 2024. 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.

For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.

Submit Your Information for Consideration

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

Associated condition: NASH

Status: Currently enrolling

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.

Primary objectives: 

Improvement in liver fibrosis and no worsening of NASH (Yes/No) [ Time Frame: From baseline (week 0) to week 52 ]

  • Count of subjects Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale

Estimated length of study:  It is estimated that the study be fully completed by September 2024. 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.

For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.

Submit Your Information for Consideration

The physicians at Digestive Healthcare of Georgia are closely monitoring the coronavirus (COVID-19) outbreak. In the interest of everyone’s health and safety we ask all patients and their guests who have a fever (100° or above), symptoms of a respiratory infection, or who may have traveled to a restricted country or may have been exposed to a person with known COVID-19, the flu or any other communicable disease to reschedule their appointments or procedures. You will not be charged for canceling/rescheduling your appointment. We will be following CDC and Georgia Department of Public Health’s recommendations for screening and management of patients. If you are at all concerned you may have a serious infectious disease, your best course of action is to seek care at your primary care physician’s office or local hospital’s emergency department.

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