| Trial ID: | L0845 |
| Source ID: | EUCTR2016-000685-39-GB
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| Associated Drug: |
Semaglutide
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| Title: |
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.
A 72-week randomised, double-blind, placebo-controlled, six-armed parallel group, multi-centre
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic steatohepatitis <br>MedDRA version: 20.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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| Interventions: |
<br>Product Name: Semaglutide B 1 mg/ml NovoPen4 <br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: semaglutide<br>CAS Number: 910463-68-2<br>Other descriptive name: SEMAGLUTIDE<br>Concentration unit: mg/ml milligram(s)/millilitre<br>
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| Outcome Measures: |
Main Objective: To compare the effect of semaglutide subcutaneous (s.c.) once daily versus placebo on histological resolution of non-alcoholic steatohepatitis (NASH).;Secondary Objective: 1. To investigate the dose-response relationship of three dose levels of semaglutide s.c. once daily (0.1 mg/day, 0.2 mg/day and 0.4 mg/day) on histological resolution of NASH.<br>2. To compare the effects of semaglutide s.c. once daily to placebo on liver-related histological parameters and biomarkers of NASH disease.<br>;Primary end point(s): NASH resolution without worsening of fibrosis (yes/no);Timepoint(s) of evaluation of this end point: After 72 weeks Secondary end point(s): 1. At least one stage of liver fibrosis improvement with no worsening of NASH (yes/no) (worsening defined as an increase of at least one stage of either lobular inflammation or hepatocyte ballooning according to NASH clinical research network (CRN) criteria).
<br>2. Change in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) (0-8)
<br>3. Change in stage of fibrosis according to the Kleiner fibrosis classification (0-4)
<br>4. Change in activity component of steatosis-activity-fibrosis (SAF) score (0-4)
<br>5. Change in fasting plasma glucose (FPG)
<br>6. Change in glycosylated haemoglobin A1c (HbA1c)
<br>7. Change in serum enhanced liver fibrosis (ELF)
<br>;Timepoint(s) of evaluation of this end point: 1. After 72 weeks
<br>2. ?€? 7. From baseline to week 72
<br>
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| Sponsor/Collaborators: |
Novo Nordisk A/S
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
288
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of trea
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| Start Date: |
22/07/2016
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
8 June 2020
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| Locations: |
United States;Greece;Finland;Spain;Austria;Russian Federation;United Kingdom;France;European Union;Canada;Belgium;Denmark;Australia;Bulgaria;Netherlands;Japan;Sweden
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000685-39
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