Use of nor-ursodeoxycholic acid for reducing liver fat

A technology for hepatic steatosis and use, applied in the field of use of demethylursodeoxycholic acid for reducing liver fat, can solve the problem of no safe and effective drugs

Pending Publication Date: 2020-06-30
DR FALK PHARMA GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are no safe and effective medications available for maintenance therapy to prevent disease progression to NASH

Method used

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  • Use of nor-ursodeoxycholic acid for reducing liver fat
  • Use of nor-ursodeoxycholic acid for reducing liver fat
  • Use of nor-ursodeoxycholic acid for reducing liver fat

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0184] Example 1: Ultrasound Examination of the Liver

[0185] method:

[0186] Ultrasonography is performed at V1 or within 4 weeks before V1 and within 1 week after V1 and at V6, specifically checking for the following:

[0187] Liver: size, echogenicity, overall findings (normal, abnormal - not clinically significant, abnormal - clinically significant.

[0188] Hepatic steatosis was assessed on a four-point scale according to the following grades:

[0189] ○ No / Minimal Steatosis: Normal echogenic properties of the liver were documented in the absence of steatosis, or: Minimal steatosis indicated by: slightly increased echogenicity of the liver relative to the right The echo is clearly visible.

[0190] o Mild steatosis: defined by moderately elevated echogenicity of the liver compared to the right kidney, slightly reduced visibility of intrahepatic vessel walls, and reduced reflectivity of the hemidiaphragm.

[0191] o Moderate steatosis: defined by moderately elevate...

Embodiment 2

[0199] Example 2: Liver stiffness measured according to Fibroscan or ARFI during the study

[0200] method:

[0201] A) If possible, perform Fibroscan at V1 or within 4 weeks before V1 and within 1 week after V1 and at V6. For measurement purposes, patients should fast.

[0202] Liver stiffness measurement / transient elastography

[0203] Fibroscan is a non-invasive device (Echosens, France) for the detection of steatosis hepatitis by vibration-controlled transient elastography. It consists of a vibrator device coupled to an ultrasound system. Signals from the device allow the stiffness of the tissue being scanned to be calculated, thereby assessing the extent of the disease. The results of liver elasticity should be expressed in hardness (kPa) and success rate (%).

[0204] During the measurement, an ultrafast pulse-echo sequence (pulse repetition frequency 6 kHz) is emitted during the propagation of a controlled shear wave. Acquisition lasts only 80 milliseconds, an...

Embodiment 3

[0226] Example 3: Liver Fat Fraction Measured by MRI and / or MRS

[0227] method:

[0228] Magnetic resonance imaging / spectroscopy (MRI / MRS) at V1 or within 4 weeks before V1 and 1 week after V1 and at V6, if available. Both MRI and MRS are MR-based methods to separate the liver signal into water and fat components. The resonance frequencies corresponding to the protons in water and the dominant protons in fat are different and can be quantified directly from the spectrogram trace.

[0229] The following formula was used to calculate liver fat fraction derived from chemical shift imaging (CSI) data:

[0230] CSI Liver Fat Score 未校正的 =SI 同相的 –SI 反相的 / 2x SI 同相的

[0231] To illustrate that differences in signal intensity are independent of fat content, in the spleen, a region of interest was also placed in the same image from which liver measurements were taken. To calculate the liver fat fraction corrected for signal intensity (measured using the spleen), the above form...

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Abstract

The present invention relates to the use of Nor-UDCA in the treatment of hepatic steatosis in patients having a hepatic fat fraction of greater than 10%.

Description

Background technique [0001] Hepatic steatosis is a disease in which excess fat accumulates in liver cells through the process of steatosis (ie, abnormal retention of lipids within cells). Hepatic steatosis may have various causes, such as excessive alcohol consumption, drug toxicity, metabolic derangements, or nutritional causes. [0002] Hepatic steatosis may turn into progressive liver inflammation (hepatitis), called steatohepatitis. This more serious condition may be called alcoholic steatohepatitis or nonalcoholic steatohepatitis (NASH). In more severe stages, patients with NASH may develop liver fibrosis and eventually cirrhosis. [0003] Current options for treating hepatic steatosis are limited. Dietary changes and lifestyle changes, including weight loss and increased physical activity, are primarily recommended. There are no safe and effective drugs available for maintenance therapy to prevent the disease from progressing to NASH. Various drugs have been or are ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/575A61P1/16
CPCA61K31/575A61P1/16A61K45/06
Inventor M.普罗埃尔斯R.格林瓦尔德M.特劳纳P.菲克特
Owner DR FALK PHARMA GMBH
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