Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Metacrine, Inc.
Study ID
NCT04702490
Phase
PHASE2
Status
Unknown

Conditions

  • Diabetes
  • Diabetes Type 2
  • Fatty Liver
  • Fatty Liver, Nonalcoholic
  • NAFLD
  • NASH
  • NASH - Nonalcoholic Steatohepatitis
  • Type 2 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MET409 Active — DRUG
    MET409 Active (50mg)
  • MET409 Placebo — DRUG
    MET409 Placebo (50mg)
  • Empagliflozin — DRUG
    Empagliflozin (10mg)

Study Details

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.

Key Dates

Start date
Dec 15, 2020
Status verified
May 2021
Primary completion
Apr 30, 2022
Completion
Jun 30, 2022

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MET409 A
    MET409 Active (50mg)
  • Placebo Comparator: MET409 P
    MET409 Placebo (50mg)
  • Experimental: MET409A +Open-Label Empagliflozin
    MET409 Active (50mg) + Empagliflozin (10mg)
  • Placebo Comparator: MET409P +Open-Label Empagliflozin
    MET409 Placebo (50mg) + Empagliflozin (10mg)

Primary Outcome Measure

Safety and tolerability of MET409 with or without empagliflozin (incidence of adverse events) [ Time Frame: Up to 28 days after last dose ]

Locations (2)

FacilityCityStateZIPSite coordinators
Metacrine Investigative SiteFort MyersFlorida33907-
Metacrine Investigative SiteSan AntonioTexas78215-

Find similar trials in Fort Myers, FL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Metacrine Investigative Site· Fort Myers, FLMetacrine Investigative Site· San Antonio, TX

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