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Completed

NCT Number: NCT03357380

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

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.

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Key information

Conditions

Hepatobiliary Disorders Digestive System Diseases Fatty Liver Liver Diseases Non-Alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Mainz, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

semaglutide

Drug

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

Drug

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 outcomes

  1. Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)

    Time frame: Up to day -20, week 48

    Measured in KPa

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2017
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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