| Trial ID: | L3484 |
| Source ID: | NCT05464784
|
| Associated Drug: |
Mn-001
|
| Title: |
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Hypertriglyceridemia|Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
DRUG: MN-001|DRUG: MN-001 placebo
|
| Outcome Measures: |
Primary: Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24, Week 24|Mean change from baseline in fasting serum triglyceride levels at Week 24, Week 24 | Secondary: Safety and tolerability of MN-001, Incidence of adverse events, abnormal clinical laboratory results, Baseline to Week 24|Mean change from baseline in lipids, Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks, Baseline to Week 24
|
| Sponsor/Collaborators: |
Sponsor: MediciNova
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-08-22
|
| Completion Date: |
2026-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-04-08
|
| Locations: |
Jubilee Clinical Research, Inc., Las Vegas, Nevada, 89106, United States|Pinnacle Clinical Research at South Texas Research Institute, Edinburg, Texas, 78539, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05464784
|
