2022-500366-10-00CompletedPhase 2
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 May 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 19 Oct 2022
- Start date
- 9 Jan 2024
- Lead sponsor
- Region Skane
- Diseases
- Fatty liver disease (MASLD/MASH)
- EU CT number
- 2022-500366-10-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- *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
Other illness
- *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
Other
- *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
Who the study is looking for
- *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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.