Combined Active Treatment in Type 2 Diabetes with NASH

Sponsor
German Diabetes Center
Study ID
NCT04639414
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Non-alcoholic Steatohepatitis (NASH)
  • Type 2 Diabetes

Eligibility Criteria

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

Interventions

Study Details

The aim of this multicentre, prospective, placebo-controlled, double-blind, randomized, 3-arm parallel group, interventional study is to assess for the first time the effects of either a combined therapy with the antihyperglycemic drugs semaglutide and empagliflozin or empagliflozin monotherapy compared to placebo as potential treatments for non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes.

Key Dates

Start date
Mar 26, 2021
Status verified
Oct 2024
Primary completion
Jan 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combined treatment with Empagliflozin and Semaglutide
    Combined treatment with Empagliflozin, film-coated tablet, 10mg once daily and Semaglutide, colourless solution in pre-filled pen, 1mg once weekly
  • Experimental: Empagliflozin monotherapy
    Empagliflozin, film-coated tablet, 10mg once daily and Placebo matching Semaglutide (colourless solution in pre-filled pen, once weekly)
  • Placebo Comparator: Placebo
    Placebo matching Empagliflozin (film-coated tablet, once daily) and Placebo matching Semaglutide (colourless solution in pre-filled pen, once weekly)

Primary Outcome Measure

Histological resolution of NASH without worsening of fibrosis [ Time Frame: from baseline to 48 weeks ]

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