- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987451
A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage
March 24, 2023 updated by: Novo Nordisk A/S
Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Clichy, France, 92110
- Novo Nordisk Investigational Site
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Lyon Cedex 4, France, 69317
- Novo Nordisk Investigational Site
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Paris, France, 75014
- Novo Nordisk Investigational Site
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Paris, France, 75651
- Novo Nordisk Investigational Site
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Venissieux, France, 69200
- Novo Nordisk Investigational Site
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Frankfurt, Germany, 60590
- Novo Nordisk Investigational Site
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Leipzig, Germany, 04103
- Novo Nordisk Investigational Site
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Mainz, Germany, 55131
- Novo Nordisk Investigational Site
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Barcelona, Spain, 08035
- Novo Nordisk Investigational Site
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Sevilla, Spain, 41013
- Novo Nordisk Investigational Site
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Birmingham, United Kingdom, B15 2TH
- Novo Nordisk Investigational Site
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London, United Kingdom, SE5 9RS
- Novo Nordisk Investigational Site
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Novo Nordisk Investigational Site
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Nottingham, United Kingdom, NG7 2UH
- Novo Nordisk Investigational Site
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Arizona
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Chandler, Arizona, United States, 85224
- Novo Nordisk Investigational Site
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Peoria, Arizona, United States, 85381
- Novo Nordisk Investigational Site
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California
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Coronado, California, United States, 92118
- Novo Nordisk Investigational Site
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La Jolla, California, United States, 92037
- Novo Nordisk Investigational Site
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Rialto, California, United States, 92377
- Novo Nordisk Investigational Site
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Florida
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Boca Raton, Florida, United States, 33434
- Novo Nordisk Investigational Site
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Gainesville, Florida, United States, 32610
- Novo Nordisk Investigational Site
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Miami, Florida, United States, 33136
- Novo Nordisk Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30309
- Novo Nordisk Investigational Site
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Marietta, Georgia, United States, 30060
- Novo Nordisk Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46202
- Novo Nordisk Investigational Site
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South Bend, Indiana, United States, 46635
- Novo Nordisk Investigational Site
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Kentucky
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Lexington, Kentucky, United States, 40508
- Novo Nordisk Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21202
- Novo Nordisk Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Novo Nordisk Investigational Site
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Michigan
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Detroit, Michigan, United States, 48202
- Novo Nordisk Investigational Site
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North Carolina
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Durham, North Carolina, United States, 27710
- Novo Nordisk Investigational Site
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Tennessee
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Germantown, Tennessee, United States, 38138
- Novo Nordisk Investigational Site
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Hermitage, Tennessee, United States, 37076
- Novo Nordisk Investigational Site
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Nashville, Tennessee, United States, 37211
- Novo Nordisk Investigational Site
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Texas
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Arlington, Texas, United States, 76012
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75390-8887
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78215
- Novo Nordisk Investigational Site
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Virginia
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Richmond, Virginia, United States, 23298
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Semaglutide
Dose escalation to 2.4 mg of semaglutide once-weekly
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Semaglutide given subcutaneously (s.c., under the skin) once-weekly for 48 weeks
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Placebo Comparator: Placebo
Semaglutide placebo once-weekly
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Semaglutide placebo s.c.
given once-weekly for 48 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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At least 1 stage of liver fibrosis improvement with no worsening of NASH after 48 weeks (yes/no) (worsening defined as an increase of at least one stage of either lobular inflammation, hepatocyte ballooning or steatosis according to NASH CRN criteria)
Time Frame: From baseline (week 0) to visit 12 (week 48)
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Yes/no
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From baseline (week 0) to visit 12 (week 48)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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Ratio to baseline
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From baseline (week 0) to visit 12 (week 48)
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Relative change in liver stiffness measured by MRE
Time Frame: From baseline (week 0) to visit 12 (week 48)
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Ratio to baseline
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From baseline (week 0) to visit 12 (week 48)
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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)
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Yes/no
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From baseline (week 0) to visit 12 (week 48)
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Change in stage of fibrosis according to the NASH CRN fibrosis score
Time Frame: From baseline (week 0) to visit 12 (week 48)
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Scale (0-4) (range of values on absolute scale at one time-point)
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From baseline (week 0) to visit 12 (week 48)
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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)
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Scale (0-8) (range of values on absolute scale at one time-point)
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From baseline (week 0) to visit 12 (week 48)
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Number of treatment emergent adverse events
Time Frame: From baseline (week 0) to visit 12 (week 48)
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Count
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From baseline (week 0) to visit 12 (week 48)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2019
Primary Completion (Actual)
April 22, 2021
Study Completion (Actual)
June 10, 2021
Study Registration Dates
First Submitted
June 12, 2019
First Submitted That Met QC Criteria
June 12, 2019
First Posted (Actual)
June 17, 2019
Study Record Updates
Last Update Posted (Actual)
March 30, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9931-4492
- U1111-1224-4062 (Other Identifier: World Health Organization (WHO))
- 2018-004484-31 (Registry Identifier: European Medicines Agency (EudraCT))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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