| Trial ID: | L0079 |
| Source ID: | NCT03357380
|
| Associated Drug: |
Semaglutide
|
| Title: |
A Study on How Semaglutide Works on Early Stages of Scar Tissue in the Liver Assessed by Pictures of the Liver
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Hepatobiliary Disorders|Non-alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Semaglutide|Drug: Placebo
|
| Outcome Measures: |
Change in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)|Change in relative liver fat content (%) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)|Change in absolute liver fat volume (L) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)|Proportion of subjects with at least 30% reduction in relative liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF)|Proportion of subjects with at least 15% reduction in liver stiffness assessed by magnetic resonance elastography (MRE)|Change in visceral adipose tissue (L) assessed by magnetic resonance imaging (MRI)|Change in abdominal subcutaneous adipose tissue (L) assessed by magnetic resonance imaging (MRI)|Change in Body weight (% and kg)|Change in Waist circumference|Change in Body mass index (BMI)|Number of treatment-emergent adverse events (TEAEs)|Number of treatment-emergent hypoglycaemic episodes
|
| Sponsor/Collaborators: |
Novo Nordisk A/S
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
67
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
November 28, 2017
|
| Completion Date: |
March 20, 2020
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 22, 2021
|
| Locations: |
Novo Nordisk Investigational Site, Mainz, Germany|Novo Nordisk Investigational Site, Neuss, Germany
|
| URL: |
https://ClinicalTrials.gov/show/NCT03357380
|
