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Research study on whether a combination of 2 medicines (NNC0194-0499 and Semaglutide) works in people with non-alcoholic steatohepatitis (NASH)
EU CTIS ID: 2023-506961-74-00
What this study is testing
To confirm the effect of NNC0194-0499 30 mg once weekly in combination with semaglutide 2.4 mg once weekly versus placebo once weekly on fibrosis in subjects with NASH and fibrosis stage 2−4 (F2−F4).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged ≥ 18 years at the time of signing informed consent. In Republic of Korea, subjects must be aged ≥ 19 years. In Japan, subjects must be aged ≥ 20 years. In Singapore, subjects must be aged ≥ 21 years.
- Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to Visit 1.
- 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.
You likely can't join if
- 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.
- For subjects with F4, presence or history of gastro-oesophageal varices ≥ grade 2 at V3. An oesophagogastroduodenoscopy performed no more than 52 weeks prior to V3 must be available at V3.
- 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)).
- Treatment with vitamin E (at doses ≥ 800 IU/day) or pioglitazone or medications approved for the treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
See the full eligibility criteria
- Aged ≥ 18 years at the time of signing informed consent. In Republic of Korea, subjects must be aged ≥ 19 years. In Japan, subjects must be aged ≥ 20 years. In Singapore, subjects must be aged ≥ 21 years.
- Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to Visit 1.
- 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.
- For subjects with F4, presence or history of gastro-oesophageal varices ≥ grade 2 at V3. An oesophagogastroduodenoscopy performed no more than 52 weeks prior to V3 must be available at V3.
- 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)).
- Treatment with vitamin E (at doses ≥ 800 IU/day) or pioglitazone or medications approved for the treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
- Treatment with GLP-1 RAs within 90 days prior to V2A. Subjects with a historical liver biopsy taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs from time of biopsy until V2A.
- Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- India
- Korea, Democratic People's Republic of
- Canada
- Taiwan
- Turkey
- Australia
- Japan
- Russian Federation
- United States
- Malaysia
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; India; Korea, Democratic People's Republic of; Canada; Taiwan; Turkey and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.