Effect of treatment with Semaglutide on cognitive function, brain inflammation and nitrogen-conversion in the liver in patients with non-alcoholic steatohepatitis: A randomized placebo-controlled trial

Effect of treatment with Semaglutide on cognitive function, neuroinflammation and hepatic nitrogen metabolism in patients with non-alcoholic steatohepatitis: A randomized placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004373-50-DK

Enrollment

Registered

2020-12-15

Start date

2021-04-08

Completion date

Unknown

Last updated

2024-11-04

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

Conditions

Non-alcoholic steatohepatitis MedDRA version: 22.0 Level: PT Classification code 10053219 Term: Non-alcoholic steatohepatitis System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Product Name: Semaglutide B 3.0 mg/ml PDS290 Pharmaceutical Form: Solution for injection INN or Proposed INN: Semaglutide CAS Number: 910463-68-2 Other descriptive name: SEMAGLUTIDE Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 - 69 years. 2. Biopsy-proven NASH 3. Understands and speaks Danish 4. Alcohol consumption =65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: 1. Known chronic inflammatory disease 2. Contraindication for liver biopsy: Anamnestic, clinical or laboratory signs of hemorrhagic diatesis, infection at the insertion area or focal changes in the liver 3. Diabetes Mellitus type 1 or 2 (HbA1c > 48 mmol/mol) 4. Bacterial infection 5. Known cancer 6. Known neurolodegenerative disease 7. Known severe impairment of hearing or eye sight 8. Known allergy towards one or more ingredients in the Ozempic® formula 9. Treatment with antipsychotics or other psychotropic drugs with sedative effects 10. Treatment with corticosteroids within the past 8 weeks 11. Breastfeeding 12. Pregnancy demonstrated by a positive pregnancy test or desire to become pregnant and no use of safe anti-conception (p-pills, intrauterine device, sterilised)

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To investigate how treatment with Semaglutide affects known factors involved in cognitive problems in patients with liver disease, here brain inflammation and impaired nitrogen conversion in the liver.;Primary end point(s): Change in cognitive function assessed by the Portosystemic Encephalopathy (PSE) test – measured as Portosystemic Hepatic Encephalopathy Score (PHES).;Timepoint(s) of evaluation of this end point: 6 months (28 weeks).;Main Objective: To investigate the effect of treatment with Semaglutide on cognitive function in patients with non-alcoholic steatohepatitis.	—

Measure

Time frame

Secondary Objective: To investigate how treatment with Semaglutide affects known factors involved in cognitive problems in patients with liver disease, here brain inflammation and impaired nitrogen conversion in the liver.;Primary end point(s): Change in cognitive function assessed by the Portosystemic Encephalopathy (PSE) test – measured as Portosystemic Hepatic Encephalopathy Score (PHES).;Timepoint(s) of evaluation of this end point: 6 months (28 weeks).;Main Objective: To investigate the effect of treatment with Semaglutide on cognitive function in patients with non-alcoholic steatohepatitis.

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Secondary

Measure	Time frame
Secondary end point(s): • Change in attention and psychomotor speed assessed by continuous reaction time (CRT) – measured as Index score. • Change in function of separate cognitive domains assessed by a neuropsychological test battery – measured as test scores in individual neuropsychological tests. • Change in neuroinflammation assessed by PET/MRI of the brain – measured as 11C-PK11195 binding potential in brain regions. • Change in systemic inflammation assessed by levels of proinflammatory cytokines in blood. • Change in hepatic urea synthesis function assessed by the Functional Hepatic Nitrogen Clearance (FHNC) method – measured as FHNC. • Change in NASH severity assessed by histological examination of tissue from liver biopsy – measured as NAS-score and Kleiner fibrosis grade.;Timepoint(s) of evaluation of this end point: 1 month (4 weeks) and 6 months (28 weeks).	—

Measure

Time frame

Secondary end point(s): • Change in attention and psychomotor speed assessed by continuous reaction time (CRT) – measured as Index score. • Change in function of separate cognitive domains assessed by a neuropsychological test battery – measured as test scores in individual neuropsychological tests. • Change in neuroinflammation assessed by PET/MRI of the brain – measured as 11C-PK11195 binding potential in brain regions. • Change in systemic inflammation assessed by levels of proinflammatory cytokines in blood. • Change in hepatic urea synthesis function assessed by the Functional Hepatic Nitrogen Clearance (FHNC) method – measured as FHNC. • Change in NASH severity assessed by histological examination of tissue from liver biopsy – measured as NAS-score and Kleiner fibrosis grade.;Timepoint(s) of evaluation of this end point: 1 month (4 weeks) and 6 months (28 weeks).

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Countries

Denmark

Contacts

Public ContactKristoffer Kjærgaard

Aarhus University Hospital

krikje@clin.au.dk4550906217

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026