Nat Commun: Berberine is well tolerated in the treatment of non-alcoholic steatohepatitis and type 2 diabetes

Non-alcoholic steatohepatitis (NASH) is a necrotizing inflammation of the liver that may lead to liver fibrosis and may progress to cirrhosis
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NASH is usually associated with obesity, diabetes , hypertension, and hyperlipidemia

Diabetes, heart vascular events lose weight may lead to improvement in the degree of liver damage diet may lead to improvement in the degree of liver injury changed the adjuvant treatment of life> change Adjuvant therapy of life>

So far, there is no approved treatment for NASH, and some pharmacological methods are being explored
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Some drugs that are undergoing advanced clinical trials include: bile acid as a farnesid X receptor (FXR) agonist, liver-targeted SCD-1 inhibitor Almaty, and thyroid hormone beta agonist resmetirom

Among them, HTD1801 (Berberine ursodeoxycholate or BUDCA) is different in structure and function from these drugs
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It is an ionic salt of berberine and ursodeoxycholic acid, and represents a molecular entity that provides the possibility of combined treatment for the single treatment of NASH and some of its comorbidities

Recently, researchers reported a prospective, randomized, double-blind, placebo-controlled HTD1801 trial (berberine ursodeoxycholic acid, ionic salt of berberine and ursodeoxycholic acid), which was tested at 100 In patients with fatty liver and diabetes (NCT03656744)
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The treatment time was 18 weeks, and the primary end point was a decrease in liver fat content as measured by proton density fat component of magnetic resonance imaging

Prospective, randomized, double-blind, placebo-controlled HTD1801 trial Prospective, randomized, double-blind, placebo-controlled HTD1801 trial

Schematic diagram of clinical research process

Schematic diagram of clinical research process Schematic diagram of clinical research process

The results show that the pre-specified primary endpoint has been reached
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The reduction in liver fat content in subjects who received 1000 mg of berberine ursodeoxycholate twice a day was significantly greater than in subjects who received placebo (mean absolute reduction was -4.

The pre-specified primary endpoint has reached the pre-specified primary endpoint .

Berberine ursodeoxycholate assumptions of NASH has broad metabolic activity and diabetes berberine ursodeoxycholate assumptions of NASH has broad diabetes and metabolic activity

Original source:

Stephen A.

A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes.

 

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