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Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05423327
Collaborator
(none)
8,000
Enrollment
48
Locations
1
Arm
18.1
Anticipated Duration (Months)
166.7
Patients Per Site
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: No Intervention
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
N/A: No study drug administeredN/A: No study drug administered
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Cross-Sectional Study to Determine Distribution of Genetic Variants Among Subjects at Risk of, or With Known Non-alcoholic Steatohepatitis (NASH)
Actual Study Start Date :
Dec 9, 2021
Anticipated Primary Completion Date :
Jun 13, 2023
Anticipated Study Completion Date :
Jun 13, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Single Blood Draw

Procedure: No Intervention
Single blood draw

Outcome Measures

Primary Outcome Measures

  1. Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13) [Day 1]

  2. Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3) [Day 1]

Secondary Outcome Measures

  1. Distribution of fibrosis-4 (FIB-4) scores across participants with different genotypes of rs72613567 in HSD17B13 [Day 1]

  2. Distribution of FIB-4 scores across participants with different genotypes of rs738409 in PNPLA3B13 [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
One or more of the following:

  1. A prior diagnosis of NASH with a Clinical Research Network (CRN) fibrosis score of F1 to F4 based on liver biopsy

  2. 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

  1. Known high-risk genotype for HSD17B13 (T/T or T/TA) and/or PNPLA3 (C/G,or G/G)

  2. A clinical suspicion of NASH based on presence of 2 or more elements of the metabolic syndrome defined by:

  3. Waistline that measures >35 inches (89 centimeters) for women or >40 inches (102 centimeters) for men

  4. Historic fasting triglycerides >150 mg/dL within the prior 6 months

  5. 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

  6. Historic fasting blood glucose >100 mg/dL or on diabetes medication within the prior 6 months

  7. Historic blood pressure >130/85 mmHg, or on anti-hypertensive medication within the prior 6 months

Key Exclusion Criteria:

  1. 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.

  2. 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]).

  3. History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score >12.

  4. History of viral and resolved hepatitis or human immunodeficiency virus (HIV).

  5. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southern California Research Center Coronado California United States 92118
2 Velocity Clinical Research Gardena California United States 90247
3 UCSD Health System La Jolla California United States 92037-0887
4 National Research Institute Los Angeles California United States 90057
5 Clinnova Research Solutions Orange California United States 92868
6 National Research Institute Panorama City California United States 91402
7 FEMZ Clinical Research Redondo Beach California United States 90277
8 Inland Empire Liver Foundation Rialto California United States 92377
9 Precision Research Institute, Llc San Diego California United States 91910
10 San Fernando Valley Health Institute West Hills California United States 91304
11 Integrity Clinical Research, LLC Doral Florida United States 33166
12 Floridian Clinical Research Miami Lakes Florida United States 33016
13 Miami Clinical Research Miami Florida United States 33155
14 Genoma Research Group, Inc. Miami Florida United States 33173
15 US Associates in Research, LLC Miami Florida United States 33175
16 Links Clinical Trials Miami Florida United States 33176
17 Med Research Of Florida, LLC Miami Florida United States 33186
18 IMIC, Inc Palmetto Bay Florida United States 33157
19 Revival Research Palmetto Bay Florida United States 33157
20 Tandem Clinical Research, LLC Marrero Louisiana United States 70072
21 Mercy Medical Center, Inc Baltimore Maryland United States 21202
22 Mt. Olympus Medical Research Friendswood Texas United States 77546
23 Synergy Group US LLC Houston Texas United States 77036
24 Pioneer Research Solutions, Inc Houston Texas United States 77099
25 Liver Center of Texas Plano Texas United States 75026
26 Epic Medical Research Red Oak Texas United States 75154
27 American Research Corporation at The Texas Liver Institute San Antonio Texas United States 78215
28 R & H Clinical Research Stafford Texas United States 77477
29 Centro de Diabetes de Curitiba Ltda Curitiba Paraná Brazil 80810-120
30 Hospital de Clínicas de Porto Alegre (HCPA) Porto Alegre Rio Grande Do Sul Brazil 90035-903
31 Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda Porto Alegre Rio Grande Do Sul Brazil 90430-001
32 IBPClin-Instituto Brasil de Pesquisa Clínica - CCBR Rio de Janeiro Brazil 20241-180
33 Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo São Paulo Brazil 05403-000
34 Keimyung University Dongsan Hospital Dalseo-gu Daegu Korea, Republic of 42601
35 Seoul National University College of Medicine, Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620
36 Hanyang University Seoul Hospital Seoul Gyeonggi Korea, Republic of 04763
37 Chung-Ang University Hospital Dongjak-gu Seoul Korea, Republic of 06973
38 Seoul National University Hospital Jongno-gu Seoul Korea, Republic of 03080
39 CEDOPEC - Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C. Miguel Hidalgo Ciudad De México Mexico 11650
40 PCR Cuautitlán Izcalli Estado De México Mexico 54769
41 Grupo Médico Terranova - Hospital Terranova Guadalajara Jalisco Mexico 44670
42 Unidad de Atención Médica e Investigación en Salud (UNAMIS) Mérida Yucatán Mexico 97000
43 Investigación en Salud y Metabolismo S.C / Nutrición Clínica Chihuahua Mexico 31110
44 Dr. Federico Rodriguez-Perez MD, Office of San Juan Puerto Rico 00909
45 Latin Clinical Trial Center San Juan Puerto Rico 00909
46 VA Caribbean Healthcare System San Juan Puerto Rico 00921-3201
47 Fundación de Investigación de Diego, Inc. San Juan Puerto Rico 00927
48 Dr. Paola Mansilla-Letelier MD, Office of San Juan Puerto Rico 00969

Sponsors and Collaborators

  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05423327
Other Study ID Numbers:
  • R0000-NASH-CES-2117
First Posted:
Jun 21, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Regeneron Pharmaceuticals
Nonalcoholic fatty liver disease (NAFLD)
Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Aug 17, 2022