Effect of orlistat on LIVER fat content in obese subjects with NAFLD and High concEntrAtion of pLasma proneurotensin THrough inhibition of neurotensin secretion and action
Key facts
- Where
- Malmo, SvédországSee the site
- Phase
- 2. fázis
Where in Svédország
- Region Skane Skanes UniversitetssjukhusMalmo, SvédországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Skane
- Trial code
- EU 2022-500366-10-00
- Record updated
- 2024. május 2.
- Original description
To test if 24 weeks treatment with orlistat as compared with control therapy significantly reduces percentual Liver Fat Content (LFC%) in individuals with obesity (BMI≥30 kg/m2), presence of NAFLD as well high plasma concentration of pro-NTS (>150 pmol/L).Read full original descriptionShow less
To test if 24 weeks treatment with orlistat as compared with control therapy significantly reduces percentual Liver Fat Content (LFC%) in individuals with obesity (BMI≥30 kg/m2), presence of NAFLD as well high plasma concentration of pro-NTS (>150 pmol/L).
Inclusion: *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: *Concomitant medication with any of the following: any oral anticoagulants, any anti-epileptic medications, ciclosporin, corticosteroids, diltiazem, amiodarone, antiviral HIV therapy, levothyroxine, and acarbose; *Implants contraindicating magnetic resonance imaging such as pacemaker, metallic clips in blood vessels or brain and cochlea implant; *Participation or recent participation in a clinical study with an investigational product (within 30 days). Previous participation in this study; *Diabetes Mellitus treated with insulin; *Allergy or hypersensitivity of orlistat; *Hepatitis C; *Epilepsy; *Treatment or disease which, according to the investigator, can affect treatment or study results; *Chronic malabsorption syndrome; *Liver disease other than NAFLD; *Inflammatory bowel disease; *Irritable bowel disease; *Hypothyroidism; *Estimated glomerular filtration rate <30 mL/min; *Claustrophobia; *Alcohol intake >20g per day; *Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation; *Breast feeding; *Planned or known ongoing pregnancy; *Cholestasis.