| Trial ID: | L0769 |
| Source ID: | EUCTR2018-004484-31-GB
|
| Associated Drug: |
Semaglutide
|
| Title: |
Investigation of efficacy and safety of semaglutide s.c. once-weekly versus placebo in subjects with non-alcoholic steatohepatitis and compensated liver cirrhosis
|
| Acronym: |
--
|
| Status: |
Authorised
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic steatohepatitis
Compensated liver cirrhosis
<br>
MedDRA version: 20.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
|
| Interventions: |
<br> Product Name: Semaglutide B 3.0 mg/ml PDS290<br> Pharmaceutical Form: Solution for injection<br> INN or Proposed INN: semaglutide<br> CAS Number: 910463-68-2<br> Other descrip
|
| Outcome Measures: |
Main Objective: To investigate the effect of semaglutide subcutaneous (s.c.) 2.4 mg once-weekly on liver fibrosis compared with placebo in subjects with NASH and compensated fibrosis stage 4;<br> Secondary Objective: 1. To investigate the effect of semaglutide s.c. 2.4 mg once-weekly on NASH compared with placebo in subjects with NASH and compensated fibrosis stage 4<br> 2, To evaluate the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly compared with placebo in subjects with NASH and compensated fibrosis stage 4<br> ;Primary end point(s): Relative change in liver stiffness measured by MRE;Timepoint(s) of evaluation of this end point: From baseline (week 0) to visit 12 (week 48)<br> Secondary end point(s): 1. Relative change in liver fat content (%) measured by MRI-PDFF
<br> 2. 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, hepatocyte ballooning or steatosis according to the NASH CRN criteria)
<br> 3. NASH resolution (yes/no) (defined by the NASH CRN as lobular inflammation 0 ?€? 1 and ballooning 0)
<br> 4. Change in Stage of fibrosis according to the NASH CRN fibrosis score
<br> 5. Change in NAFLD activity score (NAS) according to the NASH CRN criteria
<br> 6. Number of treatment emergent adverse events<br> ;<br> Timepoint(s) of evaluation of this end point: All secondary endpoints:
<br> From baseline (week 0) to visit 12 (week 48)<br>
|
| Sponsor/Collaborators: |
Novo Nordisk A/S
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
69
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
<br> 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>
|
| Start Date: |
31/01/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
10 December 2019
|
| Locations: |
France;United States;European Union;Spain;United Kingdom
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004484-31
|
