Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis. - SEMA-NASH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47918

Enrollment

Registered

2019-04-23

Start date

2017-02-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic steatohepatitis

Interventions

Daily administration of semaglutide/Placebo subcutaneous in 0.1 mg, 0.2 mg or 0.4 mg.

dose-response

NASH

semaglutide

steatohepatitis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Informed consent obtained before any trial-related activities. * Male or female, aged 18-75 years (both inclusive) * Histologic evidence of NASH based on central pathologist evaluation * A histological NAS * 4 with a score of 1 or more in each sub-component of the score based on central pathologist evaluation. * NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.

Exclusion criteria

Exclusion criteria: * Known or suspected abuse of alcohol, alcohol dependence or narcotics. * Diagnosis of type 1 diabetes according to medical records. * HbA1c > 10% at screening. * History or presence of pancreatitis (acute or chronic). * Calcitonin * 50 ng/L at screening. * Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. * Body Mass Index (BMI) * 25.0 kg/m2 at the screening visit. * Female who is pregnant, breast-feeding or intends to become pregnant.

Design outcomes

Primary

Measure	Time frame
NASH resolution without worsening of fibrosis after 72 weeks (yes/no)	—

Secondary

Measure	Time frame
* At least one stage of liver fibrosis improvement with no worsening of NASH after 72 weeks (yes/no) (worsening defined as an increase of at least one stage of either lobular inflammation or hepatocyte ballooning according to NASH clinical research network (CRN) criteria). Change from baseline to week 72 in: * Non-alcoholic fatty liver disease (NAFLD) activity score (NAS) (0-8) * Stage of fibrosis according to the Kleiner fibrosis classification (0-4) * Activity component of steatosis-activity-fibrosis (SAF) score (0-4) * Fasting plasma glucose (FPG) * Glycosylated haemoglobin A1c (HbA1c) * Serum enhanced liver fibrosis (ELF)	—

Measure

Time frame

* At least one stage of liver fibrosis improvement with no worsening of NASH after 72 weeks (yes/no) (worsening defined as an increase of at least one stage of either lobular inflammation or hepatocyte ballooning according to NASH clinical research network (CRN) criteria). Change from baseline to week 72 in: * Non-alcoholic fatty liver disease (NAFLD) activity score (NAS) (0-8) * Stage of fibrosis according to the Kleiner fibrosis classification (0-4) * Activity component of steatosis-activity-fibrosis (SAF) score (0-4) * Fasting plasma glucose (FPG) * Glycosylated haemoglobin A1c (HbA1c) * Serum enhanced liver fibrosis (ELF)

—

Countries

Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Finland, France, Greece, Japan, Netherlands, Russian Federation, Spain, Sweden, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)