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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500366-10-00
Enrollment
60
Registered
2023-01-26
Start date
2024-01-09
Completion date
2025-06-02
Last updated
2024-05-02

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

Conditions

Non-Alcoholic Fatty Liver Disease

Brief summary

The primary outcome is the treatment group difference in 6-month change (LFC% at week 24 – LFC% week -1) of absolute LFC%

Detailed description

Between group (orlistat vs control) difference of 24-week change in body weight, Between group (orlistat vs control) difference of 24-week change in insulin sensitivity (assessed by the “Homeostatic Model Assessment of insulin resistance”, “HOMA-IR”), Between group (orlistat vs control) difference of 24-week change in fasting plasma glucose., Between group (orlistat vs control) difference of 24-week change in plasma glucose 2-hours after a 75 gram oral glucose load, Between group (orlistat vs control) difference of 24-week change in plasma triglycerides, Between group (orlistat vs control) difference of 24-week change in plasma LDL-cholesterol, Between group (orlistat vs control) difference of 24-week change in systolic blood pressure, Between group (orlistat vs control) difference of 24-week change in HDL-cholesterol

Interventions

DRUGOrlistat STADA 120 mg hårda kapslar

Sponsors

Region Skane
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary outcome is the treatment group difference in 6-month change (LFC% at week 24 – LFC% week -1) of absolute LFC%

Secondary

MeasureTime frame
Between group (orlistat vs control) difference of 24-week change in body weight, Between group (orlistat vs control) difference of 24-week change in insulin sensitivity (assessed by the “Homeostatic Model Assessment of insulin resistance”, “HOMA-IR”), Between group (orlistat vs control) difference of 24-week change in fasting plasma glucose., Between group (orlistat vs control) difference of 24-week change in plasma glucose 2-hours after a 75 gram oral glucose load, Between group (orlistat vs control) difference of 24-week change in plasma triglycerides, Between group (orlistat vs control) difference of 24-week change in plasma LDL-cholesterol, Between group (orlistat vs control) difference of 24-week change in systolic blood pressure, Between group (orlistat vs control) difference of 24-week change in HDL-cholesterol

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026