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Clinical Trials/CTRI/2021/03/032022
CTRI/2021/03/032022Active, not recruitingPhase 3

The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis

Novo Nordisk18 sites in 1 country1,200 target enrollmentStarted: January 4, 2021Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Enrollment
1,200
Locations
18
Primary Endpoint
Resolution of steatohepatitis and no worsening of liver fibrosisa.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

 This is a randomised, multicentre, double-blinded, parallel-group, trial comparing semaglutide s.c.  2.4 mg once weekly versus placebo s.c. once weekly in subjects with NASH and F2 or F3  (recruitment cap of approximately 20% for subjects with fibrosis stage 2). Approximately 6150  subjects will be screened to achieve 1200 subjects randomly assigned to trial product. Subjects  will be randomised 2:1 to receive either treatment with semaglutide s.c. or placebo.   Randomisation will be stratified based on the presence of T2D at screening  (defined as a medical history of T2D and/or HbA1c greater or equal to 48 mmol/mol  (greater or equal to 6.5 %)), fibrosis stage and region. For both semaglutide s.c. and   placebo there will be a period of dose escalation before reaching the target dose.  The total trial duration for each subject is approximately 257 weeks (~4 years and 11 months).  This includes a screening period of approximately 14 weeks followed by randomisation and  a 240-week treatment period.  The follow-up period is 7 weeks.

Study Design

Study Type
Interventional
Allocation
Stratified randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Subjects are eligible to be included in the trial only if all of the following criteria apply:
  • •Informed consent obtained before any trial-related activities.
  • •Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol-defined pre-screening activities, which require a separate informed consent.
  • •Ireland: See local requirements in Appendix 9 (Section 10.9).
  • •Age above or equal to 18 years at the time of signing informed consent.
  • •Japan, South Korea and Taiwan: See local requirements in Appendix 9 (Section 10.9).
  • •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 screening visit (V1).
  • •Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.
  • •A histological NAS ≥ 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
  • •China: See local requirements in Appendix 9 (Section 10.9).

Exclusion Criteria

  • •Positive HBsAg, positive anti-HIV, positive HCV-RNA at screening or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
  • •Documented causes of chronic liver disease other than Non-Alcoholic Fatty Liver Disease NAFLD.
  • •Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
  • •Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test(AUDIT questionnaire).
  • •Treatment with vitamin E (at doses greater or equal to 800 IU/day) or pioglitazone or medications approved for 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 the screening visit (V2A).
  • •In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
  • •Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A).
  • •In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening.
  • •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 the screening visit (V2A).

Outcomes

Primary Outcomes

Resolution of steatohepatitis and no worsening of liver fibrosisa.

Time Frame: Week 0 to Week 72

Improvement in liver

Time Frame: Week 0 to Week 72

fibrosis and no worsening

Time Frame: Week 0 to Week 72

of steatohepatitis.

Time Frame: Week 0 to Week 72

Time to first liver-related clinical event

Time Frame: Week 0 to Week 72

Secondary Outcomes

  • Progression of liver fibrosis(Change in body weight)

Investigators

Sponsor Class
Pharmaceutical industry-Global

Study Sites (18)

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