Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH
NCT04702490 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2021-06-01
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.
Conditions
- NASH
- NASH - Nonalcoholic Steatohepatitis
- Type 2 Diabetes
- Diabetes Type 2
- Diabetes
- Fatty Liver
- Fatty Liver, Nonalcoholic
- NAFLD
Interventions
- DRUG
-
MET409 Active
MET409 Active (50mg)
- DRUG
-
MET409 Placebo
MET409 Placebo (50mg)
- DRUG
-
Empagliflozin
Empagliflozin (10mg)
Sponsors & Collaborators
-
Metacrine, Inc.
lead INDUSTRY
Principal Investigators
-
Hubert C Chen, MD · Metacrine, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-15
- Primary Completion
- 2022-04-30
- Completion
- 2022-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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