Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

Conditions

• Non-alcoholic Steatohepatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Semaglutide administrated subcutaneously (under the skin) once weekly there will be a period of dose escalation before reaching the target dose.
• Placebo — DRUG
  Placebo administrated subcutaneously (under the skin) once weekly.

Study Details

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Key Dates

Start date

Apr 1, 2021

Status verified

Apr 2026

Primary completion

Apr 25, 2029

Completion

Apr 25, 2029

Study Design

Enrollment

1,205 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide OW (once weekly )
  Semaglutide administrated subcutaneously once weekly
• Placebo Comparator: Placebo
  Placebo administrated subcutaneously once weekly

Primary Outcome Measure

Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) [ Time Frame: From randomisation (week 0) to week 72 ]

Locations (130)

Find similar trials in Huntsville, AL

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