Patient will receive obeticholic acid (OCA) in the dose of 25 mg/day for a period of 4 months.

Patient will recieve placebo in the dose of 25 mg/day for a period of 4 months.

Familial Partial Lipodystrophy

Capsules of obeticholic acid (OCA) or an identical placebo in the dose of 25 mg/day for a period of 4 months .

Obeticholic Acid

Identical to Obeticholic Acid - placebo drug

Placebo

UT Southwestern Medical Center 5323 Harry Hines Blvd

UT Southwestern Medical Center

Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

The primary end-point variable will be the change in the liver TG content on 1H Magnetic resonance Spectroscopy (MRS).

University of Texas Southwestern Medical Center

Obeticholic acid 25 mg/day in three weeks

Obeticholic acid 25 mg/day matching placebo in three weeks

Obesity

Gallstones

Obeticholic acid

Hanns-Ulrich Marschall

Obeticholic Acid in Bariatric and Gallstone Disease

Effects of Obeticholic Acid on Hepatic Fatty Acid/Triglyceride Metabolism and Hepatobiliary Detoxification/Elimination in Morbidly Obese and Gallstone Patients

Primary endpoints
relative changes in markers for insulin resistance
relative changes in FA and TG
relative changes in hepatic and adipose tissue lipase expression and activity
relative changes in hepatic apical transport proteins ABCG5/8, BSEP, MDR3, MRP2
relative changes in hepatic ER stress markers

Secondary endpoints
relative changes in m RNA expression levels of genes listed under 3.ix
relative changes in hepatic basolateral transport proteins listed under 3.x
relative change in serum bile acids as listed under 3.xii, including INT-747
relative changes in biliary lipids (cholesterol, phospholipids, bile acids)
relative change in plasma 7α-hydroxy-4-cholesten-3-one and FGF-19
relative changes in total cholesterol, LDL-C, HDL-C, Apo A1, Apo B, in Lp(A)

oxalis corniculata/triglyceride

Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

Obeticholic Acid in Bariatric and Gallstone Disease

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