| Trial ID: | L0407 |
| Source ID: | JPRN-jRCTs031200144
|
| Associated Drug: |
Elobixibat
|
| Title: |
Comparison of colestimide /elovixibat combination therapy versus colestimide /placebo combintion in NASH patients with dyslipidemia: a multicenter, double-blind, randomized controlled study(NECST) - NECST
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH with dyslipidemia
|
| Interventions: |
Goup A: Arm Colestimide + placebo<br>Colestimide1.5g and two placebo tablets are orally administered once a day for 48 weeks.<br><br>Group B: Arm Colestimide+ erobixibat administration<br>Oral administration of colestimide1.5g and erobixibat 5mg tablets
|
| Outcome Measures: |
Absoiute change from baseline in ALT at Week 481. Improvement of fibrosis with no worsening of NASH<br>2. Resolution of NASH with no worsening of fibrosis<br>3. Improvement of fibrosis by >=1 stage or resolution of NASH without worsening of either<br>4. No worsening of fibrosis and no worsening of NASH<br>5. Improvement of NAS by >=2 with no worsening of fibrosis<br>6. Improvement of fibrosis and resolution of NASH as a composite endpoint<br>7. Improvement in fibrosis by >=2 stages<br>8. Resolution of fibrosis<br>9. >=1-point improvement in steatosis<br>10.>=1-point improvement in lobular inflammation<br>11. >=1-point improvement in hepatocellular ballooning<br>12. Change of MRE<br>13. Change of MRI-PDFF<br>14. Change of parameters in blood tests (AST, gamma-GTP, ALP, total bilirubin, total cholesterol, LDL cholesterol, triglyceride, HDL cholesterol, HbA1c), BMI, and body weight<br>15.The Change in ALT at week 48 <br>16. Change from Baseline in Risk of Cardiovascular Events (10 Year ASCVD Risk Score) at 48 Weeks of Treatment<br>17. Incidence of Adverse Events
|
| Sponsor/Collaborators: |
Kobayashi Takashi
|
| Gender: |
All
|
| Age: |
>= 20age old<= 85age old
|
| Phases: |
Phase 2
|
| Enrollment: |
40
|
| Study Type: |
Interventional
|
| Study Designs: |
randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose
|
| Start Date: |
12/10/2020
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| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
18 October 2021
|
| Locations: |
Japan
|
| URL: |
https://jrct.niph.go.jp/latest-detail/jRCTs031200144
|
