Non-alcoholic Steatohepatitis (NASH)NCT05423327
Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)
A study of Non-alcoholic Steatohepatitis (NASH), run by Regeneron Pharmaceuticals at 50 sites in 5 countries.
Trial summary
Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,311 participants
- Where
- 50 sitesin 5 countries
- Study dates
- 9 Dec 2021to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
- Historic blood pressure >130/85 mmHg, or on anti-hypertensive medication within the prior 6 months
Who cannot join
- 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 >12.
- 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
Trial locations and contacts
50 sites in 5 countries.
50 sites in 5 countries
United States30 sites
Mercy Medical Center, Inc
Baltimore, Maryland, 21202
Southern California Research Center
Coronado, California, 92118
Integrity Clinical Research, LLC
Doral, Florida, 33166
Mt. Olympus Medical Research
Friendswood, Texas, 77546
Velocity Clinical Research
Gardena, California, 90247
Mt. Olympus Medical Research
Houston, Texas, 77030
Synergy Group US LLC
Houston, Texas, 77036
Pioneer Research Solutions, Inc
Houston, Texas, 77099
UCSD Health System
La Jolla, California, 92037-0887
National Research Institute
Los Angeles, California, 90057
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
Miami Clinical Research
Miami, Florida, 33155
Genoma Research Group, Inc.
Miami, Florida, 33173
US Associates in Research, LLC
Miami, Florida, 33175
Links Clinical Trials
Miami, Florida, 33176
Med Research Of Florida, LLC
Miami, Florida, 33186
Floridian Clinical Research
Miami Lakes, Florida, 33016
Clinnova Research Solutions
Orange, California, 92868
IMIC, Inc
Palmetto Bay, Florida, 33157
Revival Research
Palmetto Bay, Florida, 33157
National Research Institute
Panorama City, California, 91402
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Liver Center of Texas
Plano, Texas, 75026
Epic Medical Research
Red Oak, Texas, 75154
FEMZ Clinical Research
Redondo Beach, California, 90277
Inland Empire Liver Foundation
Rialto, California, 92377
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, 78215
Precision Research Institute, Llc
San Diego, California, 91910
R & H Clinical Research
Stafford, Texas, 77477
San Fernando Valley Health Institute
West Hills, California, 91304
Brazil5 sites
Centro de Diabetes de Curitiba Ltda
Curitiba, Paraná, 80810-120
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda
Porto Alegre, Rio Grande do Sul, 90430-001
IBPClin-Instituto Brasil de Pesquisa Clínica - CCBR
Rio de Janeiro, 20241-180
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403-000
Mexico5 sites
Investigación en Salud y Metabolismo S.C / Nutrición Clínica
Chihuahua City, 31110
PCR
Cuautitlán Izcalli, State of Mexico, 54769
Grupo Médico Terranova - Hospital Terranova
Guadalajara, Jalisco, 44670
Unidad de Atención Médica e Investigación en Salud (UNAMIS)
Mérida, Yucatán, 97000
CEDOPEC - Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
Miguel Hidalgo, Mexico City, 11650
Puerto Rico5 sites
Dr. Federico Rodriguez-Perez MD, Office of
San Juan, 00909
Latin Clinical Trial Center
San Juan, 00909
VA Caribbean Healthcare System
San Juan, 00921-3201
Fundación de Investigación de Diego, Inc.
San Juan, 00927
Dr. Paola Mansilla-Letelier MD, Office of
San Juan, 00969
South Korea5 sites
Keimyung University Dongsan Hospital
Dalseo-gu, Daegu, 42601
Chung-Ang University Hospital
Dongjak-gu, Seoul, 06973
Seoul National University Hospital
Jongno-gu, Seoul, 03080
Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Hanyang University Seoul Hospital
Seoul, Gyeonggi-do, 04763
About this study
Official title: Cross-Sectional Study to Determine Distribution of Genetic Variants Among Subjects at Risk of, or With Known Non-alcoholic Steatohepatitis (NASH)
Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- No Intervention
- Keywords
- Nonalcoholic fatty liver disease (NAFLD)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionProcedure or surgery
Single blood draw
| Study group | Role | What they receive |
|---|---|---|
| Single Blood Draw | Other | Not described Receives: Procedure: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13)
Measured: Day 1
Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)
Measured: Day 1
Secondary outcomes (2)
Distribution of fibrosis-4 (FIB-4) scores across participants with different genotypes of rs72613567 in HSD17B13
Measured: Day 1
Distribution of FIB-4 scores across participants with different genotypes of rs738409 in PNPLA3B13
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start9 Dec 2021
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- N/A: No study drug administered
- Masking
- None (open label)
- Enrolment
- 5,311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423327
- Sponsor's protocol ID
- R0000-NASH-CES-2117
- Status last verified
- Mar 2023
- First submitted
- 1 Jun 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Study to Determine Distribution of Genetic Variants Among Subjects at Risk of, or With Known Non-alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT05423327
- Acronym / sponsor ID
- R0000-NASH-CES-2117
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Keywords
- Nonalcoholic fatty liver disease (NAFLD)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 5,311 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- N/A: No study drug administered
| Arm | Type | Receives |
|---|---|---|
| Single Blood Draw | Other | Procedure: No Intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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:
Key exclusion criteria (6 listed)
- 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 >12.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionSingle blood draw | Procedure or surgery | Single Blood Draw |
Primary outcome
Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13)
Time frame: Day 1
Genotype frequencies of rs738409 in patatin-like phospholipase domain containing 3 (PNPLA3)
Time frame: Day 1
2 secondary outcomes
Distribution of fibrosis-4 (FIB-4) scores across participants with different genotypes of rs72613567 in HSD17B13
Time frame: Day 1
Distribution of FIB-4 scores across participants with different genotypes of rs738409 in PNPLA3B13
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
50 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Non-alcoholic Steatohepatitis (NASH), run by Regeneron Pharmaceuticals at 50 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Brazil, Mexico, Puerto Rico, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype frequencies of rs72613567 in Hydroxysteroid 17β dehydrogenase 13 (HSD17B13) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.