| Trial ID: | L0383 |
| Source ID: | EUCTR2020-003566-39-IT
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| Associated Drug: |
Semaglutide
|
| Title: |
Efficacy and safety investigation of NNC0194-0499 co-administered with
semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging,
placebo-controlled trial - N/A
|
| Acronym: |
--
|
| Status: |
Authorised
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| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic steatohepatitis <br>MedDRA version: 22.0
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
|
| Interventions: |
<br>Product Name: NNC0174-0833 A 10 mg/mL<br>Product Code: [N/A]<br>Pharmaceutical Form: Solution for injection in cartridge<br>Current Sponsor code: N/A<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration nu
|
| Outcome Measures: |
Main Objective: To confirm the effect of NNC0194-0499 30 mg once weekly in combination with semaglutide 2.4 mg once weekly versus placebo once weekly on fibrosis in subjects with NASH and fibrosis stage 2-4 (F2- F4).;Secondary Objective: In subjects with NASH and F2-F4:<br>?€? To investigate the dose-response relationship of NNC0194-0499 (7.5 mg, 15 mg and 30 mg) once weekly in combination with semaglutide 2.4 mg once weekly on liver histology and tolerability.<br>?€? To investigate the safety and tolerability of NNC0194-0499 30 mg once weekly alone, NC0194-0499 7.5 mg, 15 mg and 30 mg once weekly in combination with semaglutide 2.4 mg once weekly and NNC0174-0833 2.4 mg once weekly in combination with semaglutide 2.4 mg once weekly.;Primary end point(s): Improvement in liver fibrosis and no worsening of NASH (Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale. No worsening of NASH is defined as no increase from baseline in NAS score for ballooning, inflammation or steatosis.) (Yes/No).;Timepoint(s) of evaluation of this end point: From baseline (week 0) to week 52.Secondary end point(s): 1. Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)<br>2. Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)<br>3. Change in histology-assessed liver collagen proportionate area<br>4. Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)<br>5. Improvement in liver fibrosis (Yes/No)<br>6. Progression of liver fibrosis (Yes/No)<br>7. Worsening in steatohepatitis (Yes/No)<br>8. Improvement in ballooning (Yes/No)<br>9. Improvement in inflammation (Yes/No)<br>10. Improvement in steatosis (Yes/No)<br>11. Change in ALT (alanine aminotransferase)<br>12. Change in AST (aspartate aminotransferase)<br>13. Change in inflammation assessed by HsCRP (high sensitivity Creactive protein)<br>14. Change in (Enhanced Liver Fibrosis) ELF score<br>15. Change in (glycated haemoglobin) HbA1c<br>16. Change in triglycerides<br>17. Change in free fatty acids<br>18. Change in low density lipoprotein (LDL) cholesterol<br>19. Change in high density lipoprotein (HDL) cholesterol<br>20. Relative change in body weight<br>21. Change in (36-item Short Form Survey) SF-36 bodily pain<br>22. Change in Patient reported outcome measure for non-alcoholic steatohepatitis (NASH-CHECK) pain<br>23. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue score<br>24. Number of treatment emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1.-23. From baseline (week 0) to week 52<br>24. From baseline (week 0) to week 59
|
| Sponsor/Collaborators: |
NOVO NORDISK. S.P.A.
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
672
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 10
|
| Start Date: |
07/06/2021
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
30 August 2021
|
| Locations: |
United States;Israel;Russian Federation;Italy;United Kingdom;India;European Union;Canada;Malaysia;Singapore;Australia;Japan;Korea, Republic of
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003566-39
|
