Effect of orlistat on LIVER fat content in obese subjects with NAFLD and High concEntrAtion of pLasma proneurotensin THrough inhibition of neurotensin secretion and actio

Phase 1

Recruiting

• Conditions: on-Alcoholic Fatty Liver Disease; MedDRA version: 20.0Level: LLTClassification code: 10031743Term: Other chronic nonalcoholic liver disease Class: 10019805; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2022-500366-10-00
• Lead Sponsor: Region Skane

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

*Age 20-65 years, *Written informed consent, *Negative pregnancy test in women of child bearing potential (WOCBP), *Body mass index =30kg/m2, *plasma concentration of pro-NTS>150 pmol/L, *LFC% >5.6% in the absence of other causes of steatosis than NAFLD

Exclusion Criteria

*Allergy or hypersensitivity of orlistat, *Hypothyroidism, *Hepatitis C, *Epilepsy, *Concomitant medication with any of the following: any oral anticoagulants, any anti-epileptic medications, ciclosporin, corticosteroids, diltiazem, amiodarone, antiviral HIV therapy, levothyroxine, and acarbose, *Estimated glomerular filtration rate <30 mL/min, *Claustrophobia, *Implants contraindicating magnetic resonance imaging such as pacemaker, metallic clips in blood vessels or brain and cochlea implant, *Alcohol intake >20g per day, *Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation, *Treatment or disease which, according to the investigator, can affect treatment or study results., *Chronic malabsorption syndrome, *Participation or recent participation in a clinical study with an investigational product (within 30 days). Previous participation in this study., *Breast feeding, *Planned or known ongoing pregnancy, *Cholestasis, *Liver disease other than NAFLD, *Diabetes Mellitus treated with insulin, *Inflammatory bowel disease, *Irritable bowel disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified