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A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

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ClinicalTrials.gov Identifier: NCT03987451
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Drug: Semaglutide Drug: Placebo (semaglutide) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : December 29, 2020
Estimated Study Completion Date : February 16, 2021


Arm Intervention/treatment
Experimental: Semaglutide
Dose escalation to 2.4 mg of semaglutide once-weekly
Drug: Semaglutide
Semaglutide given subcutaneously (s.c., under the skin) once-weekly for 48 weeks

Placebo Comparator: Placebo
Semaglutide placebo once-weekly
Drug: Placebo (semaglutide)
Semaglutide placebo s.c. given once-weekly for 48 weeks




Primary Outcome Measures :
  1. Relative change in liver stiffness measured by magnetic resonance elastography (MRE) [ Time Frame: From baseline (week 0) to visit 12 (week 48) ]
    Ratio to baseline


Secondary Outcome Measures :
  1. Relative change in liver fat content (percent) measured by magnetic resonance imaging - Proton density fat fraction (MRI-PDFF) [ Time Frame: From baseline (week 0) to visit 12 (week 48) ]
    Ratio to baseline

  2. At least one stage of liver fibrosis improvement with no worsening of NASH (definition: an increase of at least one stage of either lobular inflammation, hepatocyte ballooning or steatosis according to the NASH Clinical Research Network (CRN) criteria) [ Time Frame: From baseline (week 0) to visit 12 (week 48) ]
    Yes/no

  3. NASH resolution (defined by the NASH CRN as lobular inflammation 0 - 1 and ballooning 0) [ Time Frame: From baseline (week 0) to visit 12 (week 48) ]
    Yes/no

  4. Change in stage of fibrosis according to the NASH CRN fibrosis score [ Time Frame: From baseline (week 0) to visit 12 (week 48) ]
    Scale (0-4) (range of values on absolute scale at one time-point)

  5. Change in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) according to the NASH CRN criteria [ Time Frame: From baseline (week 0) to visit 12 (week 48) ]
    Scale (0-8) (range of values on absolute scale at one time-point)

  6. Number of treatment emergent adverse events [ Time Frame: From baseline (week 0) to visit 12 (week 48) ]
    Count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
  • Histologic evidence of NASH and fibrosis stage 4 according to the NASH CRN classification based on central pathologist evaluation of a liver biopsy obtained within 360 days prior to screening. In subjects who have never had a liver biopsy showing NASH and F4, liver stiffness above 14 kPa by FibroScan® at screening must be documented before subjects can have a trial-related liver biopsy
  • A histological NAFLD activity score (NAS) equal to or above 3 with a score of 1 or more in lobular inflammation and hepatocyte ballooning based on central pathologist evaluation
  • Body mass index equal to or above 27 kg/m^2

Exclusion Criteria:

  • Presence or history of hepatic decompensation (e.g. ascites, variceal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis) or liver transplantation
  • Presence or history of gastroesophageal varices within the past 360 days prior to screening. For subjects with no known history of gastroesophageal varices and with a Fibroscan® equal to or above 20 kPa and thrombocytes equal to or below 150,000, a esophagogastroduodenoscopy must be performed to evaluate presence of gastroesophageal varices
  • Presence or history of hepatocellular carcinoma
  • Treatment with vitamin E (at doses equal to or above 800 IU/day) or pioglitazone which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to screening
  • Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in the period from 90 days prior to screening
  • Treatment with other glucose lowering agent(s) (apart from what is listed in the exclusion criterion above) or weight loss medication not stable in the opinion of the investigator in the period from 28 days prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987451


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03987451     History of Changes
Other Study ID Numbers: NN9931-4492
U1111-1224-4062 ( Other Identifier: World Health Organization (WHO) )
2018-004484-31 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases