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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001193-42 | Registry Identifier | European Medicines Agency (EudraCT) | |
| U1111-1194-3900 | Other Identifier | World Health Organization (WHO) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) | Measured in KPa | Up to day -20, week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) | Measured in KPa | Up to day -20, week 24 |
| Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mainz | 55116 | Germany | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34570916 | Result | Flint A, Andersen G, Hockings P, Johansson L, Morsing A, Sundby Palle M, Vogl T, Loomba R, Plum-Morschel L. Randomised clinical trial: semaglutide versus placebo reduced liver steatosis but not liver stiffness in subjects with non-alcoholic fatty liver disease assessed by magnetic resonance imaging. Aliment Pharmacol Ther. 2021 Nov;54(9):1150-1161. doi: 10.1111/apt.16608. Epub 2021 Sep 27. | |
| 33006125 |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
| 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. |
|
Measured in KPa
| Up to day -20, week 72 |
| Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Measured in Percentage (%) | Up to day -20, week 24 |
| Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Measured in Percentage (%) | Up to day -20, week 48 |
| Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Measured in Percentage (%) | Up to day -20, week 72 |
| Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Measured in Percentage (%) | Up to day -20, week 24 |
| Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Measured in L | Up to day -20, week 48 |
| Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Measured in L | Up to day -20, week 72 |
| Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Number of subjects | Weeks 0 - 24 |
| Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Number of subjects | Weeks 0 - 48 |
| Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) | Number of subjects | Weeks 0 - 72 |
| Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE) | Number of subjects | Weeks 0 - 24 |
| Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE) | Number of subjects | Weeks 0 - 48 |
| Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE) | Number of subjects | Weeks 0 - 72 |
| Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI) | Measured in L | Up to day -20, week 24 |
| Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI) | Measured in L | Up to day -20, week 48 |
| Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI) | Measured in L | Up to day -20, week 72 |
| Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI) | Measured in L | Up to day -20, week 24 |
| Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI) | Measured in L | Up to day -20, week 48 |
| Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI) | Measured in L | Up to day -20, week 72 |
| Change in Body weight (% and kg) | Measured in kg and % | Week 0, week 48 |
| Change in Body weight (% and kg) | Measured in kg and % | Week 0, week 72 |
| Change in Waist circumference | Measured in cm | Week 0, week 48 |
| Change in Waist circumference | Measured in cm | Week 0, week 72 |
| Change in Body mass index (BMI) | Measured in kg/sqm | Week 0, week 48 |
| Change in Body mass index (BMI) | Measured in kg/sqm | Week 0, week 72 |
| Number of treatment-emergent adverse events (TEAEs) | Count of adverse events | Weeks 0 - 48 |
| Number of treatment-emergent adverse events (TEAEs) | Count and % of adverse events | Weeks 0 - 79 |
| Number of treatment-emergent hypoglycaemic episodes | Count of episodes | Weeks 0 - 48 |
| Number of treatment-emergent hypoglycaemic episodes | Count of episodes | Weeks 0 - 79 |
| Neuss |
| 41460 |
| Germany |
| Derived |
| Andersen G, Plum-Morschel L, Hockings PD, Morsing A, Palle MS, Svolgaard O, Flint A. Clinical Characteristics of a Non-Alcoholic Fatty Liver Disease Population Across the Fibrosis Spectrum Measured by Magnetic Resonance Elastography: Analysis of Screening Data. Adv Ther. 2020 Dec;37(12):4866-4876. doi: 10.1007/s12325-020-01503-x. Epub 2020 Oct 1. |