Trials / Unknown
UnknownNCT04702490
Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH
A Phase 2A Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes Mellitus (T2DM) and Nonalcoholic Steatohepatitis (NASH)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Metacrine, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, multi-center study evaluating MET409 (50 mg) alone or in combination with empagliflozin (10 mg) for 12 weeks. Assignment to MET409 will be double-blind and placebo-controlled. Empagliflozin will be incorporated into two of the treatment arms in an open-label manner.
Detailed description
Subjects assigned to receive empagliflozin will be dosed at 10 mg per day for the duration of the study. Approximately 30 subjects will be enrolled per treatment arm.
Conditions
- NASH
- NASH - Nonalcoholic Steatohepatitis
- Type 2 Diabetes
- Diabetes Type 2
- Diabetes
- Fatty Liver
- Fatty Liver, Nonalcoholic
- NAFLD
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MET409 Active | MET409 Active (50mg) |
| DRUG | MET409 Placebo | MET409 Placebo (50mg) |
| DRUG | Empagliflozin | Empagliflozin (10mg) |
Timeline
- Start date
- 2020-12-15
- Primary completion
- 2022-04-01
- Completion
- 2022-06-01
- First posted
- 2021-01-11
- Last updated
- 2021-06-01
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04702490. Inclusion in this directory is not an endorsement.