Cross-Sectional Study to Determine Distribution of Genetic Variants Among Subjects at Risk of, or With Known Non-alcoholic Steatohepatitis (NASH)

Regeneron Pharmaceuticals48 sites in 5 countries5,311 target enrollmentDecember 9, 2021

ConditionsNon-alcoholic Steatohepatitis (NASH)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-alcoholic Steatohepatitis (NASH)
Sponsor: Regeneron Pharmaceuticals
Enrollment: 5311
Locations: 48
Primary Endpoint: Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)

Registry

clinicaltrials.gov

Start Date

December 9, 2021

End Date

October 27, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•One or more of the following:
•A prior diagnosis of NASH with a Clinical Research Network (CRN) fibrosis score of F1 to F4 based on liver biopsy
•Evidence of NAFLD by imaging or liver histology as described in the protocol
•The possible imaging modalities to assess historic evidence of NAFLD may be based on thresholds as described in the protocol
•Known high-risk genotype for HSD17B13 (T/T or T/TA) and/or PNPLA3 (C/G,or G/G)
•A clinical suspicion of NASH based on presence of 2 or more elements of the metabolic syndrome defined by:
•Waistline that measures \>35 inches (89 centimeters) for women or \>40 inches (102 centimeters) for men
•Historic fasting triglycerides \>150 mg/dL within the prior 6 months
•Historic fasting HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women, or on cholesterol-lowering medication within the prior 6 months
•Historic fasting blood glucose \>100 mg/dL or on diabetes medication within the prior 6 months

Exclusion Criteria

•Known history or clinical evidence of drug abuse, within the 12 months before screening. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms.
•Excessive alcohol intake for ≥3 months during the past year prior to screening (\>3 units/day for males and \>2 units/day for females is generally considered excessive (unit: 1 glass of wine \[approximately 125 mL\]=1 measure of spirits \[approximately 1 fluid ounce\]=½ pint of beer \[approximately 284 mL\]).
•History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score \>
•History of viral and resolved hepatitis or human immunodeficiency virus (HIV).
•Any malignancy within the past 5 years except for basal cell or squamous epithelial cell carcinoma of the skin, or any carcinoma in situ.
•Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Outcomes

Primary Outcomes

Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)

Time Frame: Day 1

Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13)

Time Frame: Day 1

Secondary Outcomes

Distribution of fibrosis-4 (FIB-4) scores across participants with different genotypes of rs72613567 in HSD17B13(Day 1)
Distribution of FIB-4 scores across participants with different genotypes of rs738409 in PNPLA3B13(Day 1)