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Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients

A Safety Pilot Study of Px-104 in Non-alcoholic Fatty Liver Disease (NAFLD) Patients

NCT01999101•Phenex Pharmaceuticals AG

View on ClinicalTrials.gov

Summary

The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD patients and to assess the influence of Px-104 on hepatic fat.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•NAFLD patients
•Weight \> 65 kg
•BMI \> 25 and \< 40
•Negative blood or urine pregnancy test (for females of childbearing potential) collected at screening followed by another negative serum pregnancy test collected within 24 hours prior to the first dose of study drug.
•Contraception: Female patients must be postmenopausal, surgically sterile, or if premenopausal, must be prepared to use at least two effective (≤1% failure rate) method of contraception during the course of the study and for 14 days after the end of dosing. Male patients with female partners of child bearing potential must be prepared to use at least two effective methods of contraception with all sexual partners unless they have had a prior vasectomy
•Must be willing and able to give written informed consent and agree to comply with the study protocol.
•Sinus rhythm in 12-lead ECG
•History of severe allergic
•Evidence of an active or suspected cancer, or a history of malignancy within the last 2 years, with the exception of patients with basal cell carcinoma that has been excised and cured.
•History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
+13 more criteria

Exclusion Criteria

•Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of first dose.
•History or other evidence of a medical condition associated with chronic liver disease other than.
•History or other evidence of decompensated liver disease (Child-Pugh Grade B or higher), coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, hepatic encephalopathy, and bleeding from esophageal varices are conditions consistent with decompensated liver disease.
•Concomitant intake of fibrates or statins (at least 4-6 weeks before start; considering half life of medication).
•Any clinically relevant findings in ECG (identified via 24h-Holter ECG or 12-Lead ECG) at screening
•History of any structural cardiac disease.
•In addition, patients with documented or presumed unstable coronary artery disease, stable or unstable cardiovascular disease or cerebrovascular disease.
•One or more of the following conditions: (1) poorly controlled hypertension, OR (2) screening or baseline blood pressure ≥ 160 mmHg for systolic OR (3) screening or baseline blood pressure ≥ 100 mmHg for diastolic blood pressure.
•Type I or II diabetes with HbA1C \> 6.5% at screening and/or fasting plasma glucose \> 7mmol/L (\> 126 mg/dl).
•History or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy (e.g., cytomegalovirus, macular degeneration).
+3 more criteria

Locations (1)

Division of Gastroenterology and Hepatology, Department of Internal Medicine III

Vienna, Austria

Key Dates

Start Date

October 1, 2013

Primary Completion Date

January 1, 2015

Completion Date

June 1, 2016

Last Updated

September 29, 2016

Enrollment

ACTUAL participants

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

Px-104

DRUG

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Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity

Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population

Genetics of Fatty Liver Disease in Children