| Trial ID: | L0526 |
| Source ID: | NCT03291249
|
| Associated Drug: |
Foralumab
|
| Title: |
A Randomized, Placebo-controlled ,Double-blind, Phase IIa Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis;NAFLD;T2DM (Type 2 Diabetes Mellitus)
|
| Interventions: |
Drug: Foralumab;Other: placebo;Drug: Omeprazole 20mg
|
| Outcome Measures: |
severity and duration for all adverse events;Abnormal laboratory findings;Abnormal physical findingsChange ALT levels;Change in HbA1c levels;change in HOMA/HOMA-IR scores
|
| Sponsor/Collaborators: |
Tiziana Life Sciences, PLC
|
| Gender: |
All
|
| Age: |
18 Years120 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
0
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
21/08/2017
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
--
|
| URL: |
https://clinicaltrials.gov/show/NCT03291249
|
