BridgeMD
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
EU CTIS ID: 2022-500366-10-00
What this study is testing
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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- *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
You likely can't join if
- *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
See the full eligibility 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
- *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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.