| Trial ID: | L0620 |
| Source ID: | NCT02316717
|
| Associated Drug: |
IMM-124E
|
| Title: |
A Phase ll, Randomized, Double-blind, Placebo-controlled Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis.
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT02316717
|
| Conditions: |
Non-alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Biological: IMM-124E;Other: Placebo
|
| Outcome Measures: |
Safety Outcome Measure;Percentage Fat Content of the Liver;Adverse Events;Severity of Adverse EventsSystolic Blood Pressure;Pulse Rate;Diastolic Blood Pressure;Respiratory Rate;Serum Alanine Aminotransaminase (ALT);Peak Serum Concentration (Cmax);Minimum Serum Concentration (Cmin);Area Under the Concentration Time Curve (AUC);Elimination Half Life (T1/2);Body Mass Index (BMI);Waist Circumference;Waist:Hip Ratio;Hemoglobin (HB)A1C;Homeostatic Model Assessment of Insulin Resistance (HOMA-IR);Total Cholesterol;Triglycerides;Low Density Lipoprotein (LDL);High Density Lipoprotein (HDL);Serum Alanine Aminotransaminase (ALT);Serum Aspartate Aminotransaminase (AST);Bilirubin;Albumin;Gamma Glutamyl Transpeptidase (GGT);Serum Alanine Aminotransaminase (ALT)
|
| Sponsor/Collaborators: |
Immuron Ltd.
|
| Gender: |
All
|
| Age: |
18 Years99 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
133
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
06/11/2014
|
| Completion Date: |
--
|
| Results First Posted: |
21/02/2020
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United States;Australia;Israel;Australia;Israel;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02316717
|
