| Trial ID: | L0173 |
| Source ID: | NCT03970031
|
| Associated Drug: |
MSDC-0602K
|
| Title: |
A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH
|
| Acronym: |
--
|
| Status: |
Not yet recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type2 Diabetes|NASH - Nonalcoholic Steatohepatitis|Nonalcoholic Steatohepatitis|Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: MSDC-0602K|Drug: Placebo
|
| Outcome Measures: |
Change in glycosylated hemoglobin (HbA1c) from baseline to Week 26|Change in the weighted average of standardized AST, CK-18, and HbA1c values (standard deviations) from baseline to Week 26|Time to first event of death, adjudicated nonfatal MI or USA hospitalization, adjudicated hospital admission for HF, or adjudicated nonfatal ischemic stroke.|Time to first event of death or adjudicated non-fatal MI or USA hospitalization, adjudicated hospital admission for HF, adjudicated nonfatal ischemic stroke, or liver event in all randomized subjects.
|
| Sponsor/Collaborators: |
Cirius Therapeutics, Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 80 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 3
|
| Enrollment: |
1800
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
June 2022
|
| Completion Date: |
September 2024
|
| Results First Posted: |
--
|
| Last Update Posted: |
July 12, 2021
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT03970031
|
