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A Study on How Semaglutide Works on Early Stages of Scar Tissue in the Liver Assessed by Pictures of the Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03357380
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This study is looking at the effect of semaglutide on subjects with nonalcoholic fatty liver disease.This study is comparing the change in early stages of scar tissue in the liver and fat deposition in the liver in people taking semaglutide and placebo (a dummy medicine).

Participants will either get semaglutide or placebo; which treatment participants get is decided by chance. Semaglutide is a medicine under clinical investigation. That means that the medicine has not yet been approved by the authorities. Participants will need to self-inject medicine once daily for 72 weeks. The medicine should be injected under the skin in the stomach, thigh or upper arm.

There are about 3 weeks before participants start the study medicine and 7 weeks after you stop it. The study will last for about 82 weeks in total.

Participants will have 12 clinic visits, 6 phone calls and 4 visits to an MRI centre.

The study includes MRI scans of the stomach. The MRI scans will take place at a different location. Participants will be excluded from the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Condition or disease Intervention/treatment Phase
Hepatobiliary Disorders Non-alcoholic Fatty Liver Disease Drug: Semaglutide Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 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: A Trial Investigating the Effect of Subcutaneous Semaglutide on Liver Fibrosis Assessed by Magnetic Resonance Elastography in Subjects With Non-alcoholic Fatty Liver Disease
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : March 20, 2020
Actual Study Completion Date : March 20, 2020


Arm Intervention/treatment
Experimental: Semaglutide
Semaglutide will be initiated with a starting dose of 0.05 mg/day for the first 4 weeks. The dose will be increased every 4 weeks until the target dose of 0.4 mg/day has been reached.
Drug: Semaglutide
Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.

Placebo Comparator: Placebo
Placebo will be initiated with a starting volume corresponding to 0.05 mg/day of semaglutide for the first 4 weeks. The volume will then be increased every 4 weeks until the target volume corresponding to 0.4 mg/day of semaglutide has been reached.
Drug: Placebo
Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.




Primary Outcome Measures :
  1. Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) [ Time Frame: Up to day -20, week 48 ]
    Measured in KPa


Secondary Outcome Measures :
  1. Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) [ Time Frame: Up to day -20, week 24 ]
    Measured in KPa

  2. Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) [ Time Frame: Up to day -20, week 72 ]
    Measured in KPa

  3. Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Up to day -20, week 24 ]
    Measured in Percentage (%)

  4. Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Up to day -20, week 48 ]
    Measured in Percentage (%)

  5. Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Up to day -20, week 72 ]
    Measured in Percentage (%)

  6. Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Up to day -20, week 24 ]
    Measured in Percentage (%)

  7. Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Up to day -20, week 48 ]
    Measured in L

  8. Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Up to day -20, week 72 ]
    Measured in L

  9. Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Weeks 0 - 24 ]
    Number of subjects

  10. Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Weeks 0 - 48 ]
    Number of subjects

  11. Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [ Time Frame: Weeks 0 - 72 ]
    Number of subjects

  12. Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE) [ Time Frame: Weeks 0 - 24 ]
    Number of subjects

  13. Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE) [ Time Frame: Weeks 0 - 48 ]
    Number of subjects

  14. Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE) [ Time Frame: Weeks 0 - 72 ]
    Number of subjects

  15. Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI) [ Time Frame: Up to day -20, week 24 ]
    Measured in L

  16. Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI) [ Time Frame: Up to day -20, week 48 ]
    Measured in L

  17. Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI) [ Time Frame: Up to day -20, week 72 ]
    Measured in L

  18. Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI) [ Time Frame: Up to day -20, week 24 ]
    Measured in L

  19. Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI) [ Time Frame: Up to day -20, week 48 ]
    Measured in L

  20. Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI) [ Time Frame: Up to day -20, week 72 ]
    Measured in L

  21. Change in Body weight (% and kg) [ Time Frame: Week 0, week 48 ]
    Measured in kg and %

  22. Change in Body weight (% and kg) [ Time Frame: Week 0, week 72 ]
    Measured in kg and %

  23. Change in Waist circumference [ Time Frame: Week 0, week 48 ]
    Measured in cm

  24. Change in Waist circumference [ Time Frame: Week 0, week 72 ]
    Measured in cm

  25. Change in Body mass index (BMI) [ Time Frame: Week 0, week 48 ]
    Measured in kg/sqm

  26. Change in Body mass index (BMI) [ Time Frame: Week 0, week 72 ]
    Measured in kg/sqm

  27. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Weeks 0 - 48 ]
    Count of adverse events

  28. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Weeks 0 - 79 ]
    Count and % of adverse events

  29. Number of treatment-emergent hypoglycaemic episodes [ Time Frame: Weeks 0 - 48 ]
    Count of episodes

  30. Number of treatment-emergent hypoglycaemic episodes [ Time Frame: Weeks 0 - 79 ]
    Count of episodes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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
  • Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
  • Liver steatosis greater than or equal to 10% measured by magnetic resonance imaging proton density fat fraction at screening
  • Liver stiffness between 2.50 and 4.63 kPa (both inclusive) measured by magnetic resonance elastography at screening
  • Body mass index between 25.0 and 40.0 kg/sqm (both inclusive) at the screening visit

Exclusion Criteria:

  • Known or suspected abuse of alcohol (greater than 12 g/day for women or greater than 24 g/day for men) or alcohol dependence assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)
  • Diagnosis of type 1 diabetes according to medical records
  • Glycosylated haemoglobin A1c (HbA1c) greater than 9.5% at screening
  • History or presence of pancreatitis (acute or chronic) as declared by the subject
  • Screening calcitonin greater than or equal to 100 ng/L
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject)
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods. (Highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence (only acceptable if corresponding to the preferred and usual lifestyle of the subject) or a surgically sterilised partner)

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): NCT03357380


Locations
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Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55116
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03357380    
Other Study ID Numbers: NN9931-4381
2017-001193-42 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1194-3900 ( Other Identifier: World Health Organization (WHO) )
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
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/website/content/how-to-access-clinical-trial-datasets.aspx

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases