| Trial ID: | L5213 |
| Source ID: | NCT04702490
|
| Associated Drug: |
Met409 Active
|
| Title: |
Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
NASH|NASH - Nonalcoholic Steatohepatitis|Type 2 Diabetes|Diabetes Type 2|Diabetes|Fatty Liver|Fatty Liver, Nonalcoholic|NAFLD
|
| Interventions: |
DRUG: MET409 Active|DRUG: MET409 Placebo|DRUG: Empagliflozin
|
| Outcome Measures: |
Primary: Safety and tolerability of MET409 with or without empagliflozin (incidence of adverse events), Incidence of Treatment-emergent adverse events, incidence of clinically significant changes in vital signs, abnormal laboratory safety tests, and abnormal ECGs., Up to 28 days after last dose | Secondary: Pharmacological activity of MET409 alone or in combination with empagliflozin, Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF), 16 weeks|Pharmacokinetic profile of MET409 alone or in combination with empagliflozin, Cmax, 12 weeks|Pharmacokinetic profile of MET409 alone or in combination with empagliflozin, tmax, 12 weeks|Pharmacokinetic profile of MET409 alone or in combination with empagliflozin, AUClast, 12 weeks|Pharmacodynamic profile of MET409 alone or in combination with empagliflozin, Bile acid precursor : C4 (7αhydroxy-4-cholesten-3-one), 16 weeks|Pharmacodynamic profile of MET409 alone or in combination with empagliflozin, Bile acid precursor : Fibroblast growth factor 19 (FGF19), 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Metacrine, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-12-15
|
| Completion Date: |
2022-06
|
| Results First Posted: |
|
| Last Update Posted: |
2021-06-01
|
| Locations: |
Metacrine Investigative Site, Fort Myers, Florida, 33907, United States|Metacrine Investigative Site, San Antonio, Texas, 78215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04702490
|
