Trials / Unknown
UnknownNCT03970031
A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH
MMONARCh-1: Study of MSDC-0602K, a Modulator of the Mitochondrial Pyruvate Carrier for Outcomes in Patients With Pre Type 2 Diabetes (T2D) or T2D and NAFLD/NASH, Assessed for ImpRoved Glycemic Control and Cardiovascular Outcomes-1
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,800 (estimated)
- Sponsor
- Cirius Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.
Detailed description
This is a randomized, double-blind study of MSDC-0602K or placebo given orally once daily to subjects with pre-T2D or T2D and evidence of NAFLD/NASH. Visits will include a Screening Period, a minimum Treatment of 26 weeks, and a Long-Term Follow-up Period during which subjects will continue taking assigned treatment. Safety will be assessed by periodic measurement of vital signs, physical examinations, blood laboratory analyses, and the occurrence of adverse events.
Conditions
- Type2 Diabetes
- NASH - Nonalcoholic Steatohepatitis
- Nonalcoholic Steatohepatitis
- Non-Alcoholic Fatty Liver Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MSDC-0602K | MSDC-0602K tablet |
| DRUG | Placebo | Matching tablet |
Timeline
- Start date
- 2022-06-01
- Primary completion
- 2024-09-01
- Completion
- 2024-09-01
- First posted
- 2019-05-31
- Last updated
- 2021-07-12
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03970031. Inclusion in this directory is not an endorsement.