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Non-Alcoholic SteatohepatitisPhase 2NCT04378010

A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH

A Phase 2 study testing EDP-305 1.5 mg and EDP-305 2 mg in people with Non-Alcoholic Steatohepatitis, run by Enanta Pharmaceuticals, Inc at 81 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

A randomized, double-blind study to assess the safety and efficacy of EDP-305 in subjects with liver-biopsy proven 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
What is being tested?
EDP-305 1.5 mg and EDP-305 2 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
81 sitesin 6 countries
Study dates
27 Jan 2020to 30 Nov 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Informed consent documentation signed and dated by the participant.
  • Male and female participants, of all ethnic origins, between the ages of 18 and 75 years, inclusive.
  • Participants of all ethnic origins had to have a Body Mass Index (BMI) > 25 kg/m2 and ≤ 45 except Asian participants who qualified for the study with BMI > 23 kg/m2.
  • Histological evidence of definite NASH based on NASH Clinical Research Network (CRN) criteria obtained from assessment of a liver biopsy by the central histopathologist. The biopsy may be obtained either 1) during the Screening window or 2) within 26 weeks prior to the Screening visit.
  • NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2).
  • Fibrosis stage 2 or 3 using the NASH CRN Histologic Scoring System.
Show all 10Show fewer
  • Participants had to have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA, and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. [Note: participants previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years were allowed.]
  • A woman of childbearing potential who was sexually active with a male had to agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of study drug.
  • A male participant who had not had a vasectomy and was sexually active with a woman of childbearing potential had to agree to use effective contraception from the date of Screening to 90 days after the last dose of study drug.
  • Participant had to be willing and able to adhere to the assessments, visit schedules, prohibitions and restrictions, as described in this protocol.

Who cannot join

  • Laboratory Screening results as indicated below:
  • Total white blood cells (WBC) <3000 cells/mm3
  • Absolute neutrophil count (ANC) <1500 cells/mm3
  • Platelet count <140,000/mm3
  • International Normalized Ratio, INR >1.2 (unless due to use of anticoagulants)
  • Estimated glomerular filtration rate (eGFR) < 60 mL/min according to the Modification of Diet in Renal Disease (MDRD) equation
Show all 35Show fewer
  • AST ≥5× ULN
  • ALT ≥5× ULN
  • ALP ≥2× ULN
  • Total bilirubin > 1.5 times ULN during Screening. [Note: Patients with Gilbert's syndrome were allowed following review by the Medical Monitor if they had a known history of Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count.]
  • Pregnant or nursing females.
  • MELD: Model for End-stage Liver Disease score >12.
  • Clinical or laboratory evidence of known chronic liver disease such as alcoholic liver disease, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC).
  • History of acute liver complications due to gallstones (e.g., acute cholecystitis or acute biliary obstruction) unless the participant had a cholecytectomy (more than 3 months prior to screening).
  • History of liver transplant, or current placement on a liver transplant list.
  • Hepatorenal syndrome (type I or II).
  • Prior variceal hemorrhage, uncontrolled encephalopathy, liver cirrhosis Child-Pugh Class A, B, and C, esophageal varices, or refractory ascites within the previous 26 weeks of Screening and/or histological presence of liver cirrhosis.
  • Prior or planned ileal resection, or prior or planned bariatric surgery. [Note: Participants who had undergone gastric surgeries that did not affect drug absorption (e.g., gastric band or gastric sleeve procedures) were allowed if they were stable for at least 1 year prior to Screening. Gastrectomy or Roux-en-Y bypass was allowed if stable for at least 3 years prior to Screening.]
  • Participants with clinically or otherwise documented cardiovascular or cerebrovascular disease including clinically significant anomalies of rhythm or pattern of ECG, that in the judgement of the Principal Investigator (PI) could affect the safety of the participant or their ability to comply with the study requirements.
  • HbA1c ≥ 9.5% within 60 days prior to Day 1.
  • Use of a new antidiabetic regimen in the months prior to Screening including metformin, glucagon-like peptide (GLP) 1 agonists, sodium glucose cotransporter-2 (SGLT2) inhibitors, sulfonylureas, or dipeptidyl peptidase 4 (DPP4) inhibitors, insulin or peroxisome proliferator-activated receptor (PPAR)γ agonists (e.g., pioglitazone or rosiglitazone). For pre-existing antidiabetic treatment, participants were to be on a stable dose of antidiabetic drugs: (1) for at least 8 weeks (for metformin and/or sulfonylureas), (2) 12 weeks (for SGLT2 or DPP4 inhibitors), or (3) 12 weeks (for GLP-1 receptor agonists and thiazolidinediones) prior to Screening with the intention to keep the regimen stable during the study.
  • Use of a new statin regimen or other lipid lowering agents from 12 weeks prior to Screening.
  • Use of a new fibrate regimen from 12 weeks prior to Screening.
  • Participants with contraindications to MRI imaging, or not being able to have the MRI performed.
  • Participant had received any investigational agent (including investigational vaccine) or biological product within 30 days or 5 times the half-life (whichever was longer) prior to the planned first dose of study drug.
  • Use of an experimental or approved treatment for NASH within 26 weeks of Screening.
  • Prior use of OCA within 26 weeks of Screening and/or concurrent treatment with OCA (or any other FXR agonists).
  • Use of systemic immunosuppressant (e.g., corticosteroids) for more than 4 weeks in duration within 1 year prior to Screening with the intention to continue during the study (chronic use of inhaled, topical, ophthalmological, nasal corticosteroids was allowed)
  • Use of any prohibited concomitant medications, including systemic CYP3A4 inhibitors and inducers, within 14 days prior to the first dose of study drug and for the duration of the study.
  • Clinically significant history of drug sensitivity or drug allergy, as determined by the PI.
  • Current or history of significant alcohol consumption defined as: >14 standard drinks per week and/or ≥4 standard drinks per occasion for males and >7 standard drinks per week and/or ≥3 standard drinks per occasion for females.
  • History of substance (including alcohol) abuse and in the judgement of the PI, the participant was not suitable for participation in the study.
  • Any other condition(s) that would compromise the safety of the participant or compromise the quality of the clinical study, as judged by the PI.
  • Use of medication for weight loss or appetite reduction (e.g., orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin, non-prescription supplements) at Screening.
  • History of malignancy of any organ system (other than localized and considered cured cutaneous basal or squamous cell carcinoma, or in situ cervical cancer), treated or untreated, within 5 years of Screening.

Trial locations and contacts

81 sites in 6 countries.

81 sites in 6 countries

United States68 sites

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749

  • Rajeev Krishan, MD, Inc

    Bakersfield, California, 93309

  • University of Maryland

    Baltimore, Maryland, 21201

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • Arizona Liver Health

    Chandler, Arizona, 85224

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center - University Cardiovascular Surgeons

    Chicago, Illinois, 60612-3852

  • eStudy Site

    Chula Vista, California, 91911

  • Cleveland Clinic - Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Northeast GI Research Division

    Concord, North Carolina, 28027

  • Southern California Research Center

    Coronado, California, 92118

  • Crescent Health Clinical

    DeSoto, Texas, 75115

  • Henry Ford Health Hospital

    Detroit, Michigan, 48202

  • Universal Axon Clinical Research

    Doral, Florida, 33166

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Intercity Gastroenterology

    Fresh Meadows, New York, 11366

  • St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • National Institute of Clinical Research, Inc

    Garden Grove, California, 92844

  • DHAT Research Institute

    Garland, Texas, 75044

  • The Institute of Liver Health

    Glendale, Arizona, 85306

  • Mid-Atlantic GI Research

    Greenbelt, Maryland, 20770

  • Digestive Health Research, LLC

    Hermitage, Tennessee, 37076

  • Universal Axon- Homestead, LLC

    Homestead, Florida, 33030

  • Carolinas HealthCare System Digestive - Huntersville

    Huntersville, North Carolina, 28078

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • University Of Iowa Hospital & Clinics

    Iowa City, Iowa, 52242

  • Southern Therapy and Advanced Research LLC GI Associates and Endoscopy Center

    Jackson, Mississippi, 39216

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic

    Jacksonville, Florida, 32226

  • Encore Borland Groover Clinical Research

    Jacksonville, Florida, 32256

  • eStudySite - La Mesa

    La Mesa, California, 91942

  • Meridien Research

    Lakeland, Florida, 33803

  • Om Research LLC

    Lancaster, California, 93534

  • Digestive Health Research

    Lebanon, Tennessee, 37090

  • Keck Medical Center Of USC

    Los Angeles, California, 90033

  • Meridien Research

    Maitland, Florida, 32751

  • Research Associates of South Florida

    Miami, Florida, 33134

  • University of Miami, Miller School of Medicine-Don Soffer Clinical Research Center

    Miami, Florida, 33136

  • Well Pharma Medical Research, Corp.

    Miami, Florida, 33173

  • Med Research Of Florida, LLC

    Miami, Florida, 33186

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Lucas Research

    Morehead City, North Carolina, 28557

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Ochsner Health System

    New Orleans, Louisiana, 70115-6969

  • New York University Medical Centre

    New York, New York, 10016

  • Bon Secours St. Mary's Hospital of Richmond, Inc

    Newport News, Virginia, 23602

  • Ocala GI Research

    Ocala, Florida, 34471

  • IMIC, Inc.

    Palmetto Bay, Florida, 33157

  • Dignity Health DBA St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center - Center for Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • University of Rochester Medical Center School of Medicine and Dentistry

    Rochester, New York, 14642

  • UC Davis Medical Center

    Sacramento, California, 95817

  • American Research Corporation at The Texas Liver Institute

    San Antonio, Texas, 78215

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Southern California Gastrointestinal and Liver Centers

    San Clemente, California, 92673

  • Precision Research Institute, Llc

    San Diego, California, 92114

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • Digestive Research Alliance of Michiana

    South Bend, Indiana, 46635

  • St. Louis Univ. School Of Medicine

    St Louis, Missouri, 63104

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Guardian Angel Research

    Tampa, Florida, 33614

  • Paradigm Clinical Research Institute

    Torrance, California, 90502

  • Del Sol Research Management LLC

    Tucson, Arizona, 85710

Other trials in United States

United Kingdom8 sites

  • MeDiNova Northampton Dedicated research site

    Corby, Northamptonshire, NN18 9EZ

  • MeDiNova Warwickshire Quality Research Site

    Kenilworth, Warwickshire, CV81JD

  • King's College Hospital - King's College Hospital NHS Foundation Trust

    London, Greater London, SE5 9RS

  • MeDiNova North London Quality Research Site

    Middlesex, HA6 2RN

  • MeDiNova East London Quality Research Site

    Romford, Essex, RM1 3PJ

  • MeDiNova Yorkshire Quality Research Site

    Shipley, Yorkshire, BD18 3SA

  • MeDiNova South London Quality Research Site

    Sidcup, Kent, DA14 6LT

  • MediNova West London Quality Research Site

    Wokingham, Berkshire, RG40 1XS

Other trials in United Kingdom

Germany2 sites

  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Argentina1 site

  • CINME

    Buenos Aires, Buenos Aires F.D., C1056AB

Other trials in Argentina

Canada1 site

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

Puerto Rico1 site

  • Latin Clinical Trial Center

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 2b Randomized, Double-Blind, Placebo-controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects With Liver Biopsy Proven Non-alcoholic Steatohepatitis (NASH) (ARGON-2)

A randomized, double-blind study to assess the safety and efficacy of EDP-305 in subjects with liver-biopsy proven Non-Alcoholic Steatohepatitis (NASH)

Read the detailed description

The aim of this Phase 2b study aimed to evaluate safety and efficacy of the investigational novel FXR agonist, EDP-305, in a population of patients with liver biopsy proven NASH.

This Phase 2b study aimed to evaluate the safety and efficacy of two doses of EDP-305 compared to placebo for the treatment of NASH in subjects with liver biopsy proven NASH. As suggested in the FDA guidance, this late stage Phase 2 study explored the effect of EDP-305/placebo treatment on histological endpoints. The patient population selected for inclusion in the study was designed to represent the target population for treatment. Specifically, in patients with liver disease, there is a significant overlap of NASH and various metabolic conditions including obesity and T2DM. In order to be reflective of the NASH population, these patients were not excluded from participation in this study.

Being tested
EDP-305 1.5 mg, EDP-305 2 mg, Placebo
Keywords
Fatty Liver, non-alcoholic fatty liver disease, NASH
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EDP-305 1.5 mgDrug

    Also called EDP-305

    Tablet

  • EDP-305 2 mgDrug

    Also called EDP-305

    Tablet

  • PlaceboDrug

    Tablet

Study groups in NCT04378010
Study groupRoleWhat they receive
EDP-305 1.5 mgExperimentalOnce a day orally for 72 weeks
Receives: Drug: EDP-305 1.5 mg
EDP-305 2 mgExperimentalOnce a day orally for 72 weeks
Receives: Drug: EDP-305 2 mg
PlaceboPlacebo comparatorOnce a day orally for 72 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants Who Achieve ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis and/or Resolution of Steatohepatitis and no Worsening of Liver Fibrosis as Determined by Liver Biopsy

    Proportion of participants who achieve ≥1 stage improvement in fibrosis without worsening of steatohepatitis and/or resolution of steatohepatitis and no worsening of liver fibrosis as determined by liver biopsy.

    Measured: Week 72

Secondary outcomes (20)

  1. Change in 5D-itch Scale From Baseline

    5D-itch scale, change from baseline at Week 12. Change from baseline for 5D-itch scale was analyzed using a restricted maximum likelihood-based mixed model repeated measures (MMRM) technique. The model included treatment, visit, treatment-by-visit interaction as fixed effects along with baseline NAS score and baseline score for 5D-itch scale as covariate.

    A multidimensional 5D-itch scale developed by Elman (Elman et al., 2010) indicated sum of 0-2 = score of 1, sum of 3-5 = score of 2, sum of 6-10 = score of 3, sum of 11-13 = score of 4, and sum of 14-16 = score of 5. The total 5D score was obtained by summing up the five domain scores and ranges between 5 (no pruritus) and 25 (most severe pruritus).

    Measured: Baseline, Week 12

  2. Proportion of Participants With Improvement of Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either as Determined by Liver Biopsy

    Description of endpoint is Proportion of participants with improvement of fibrosis by at least 1 stage and/or resolution of NASH without worsening of either as determined by liver biopsy.

    Measured: Week 72

  3. Proportion of Participants With no Worsening of Fibrosis Combined With no Worsening of NASH as Determined by Liver Biopsy

    Proportion of participants with no worsening of fibrosis combined with no worsening of NASH as determined by liver biopsy.

    Measured: Week 72

  4. Proportion of Participants With Resolution of Fibrosis as Determined by Liver Biopsy

    Proportion of participants with resolution of fibrosis as determined by liver biopsy at Week 72.

    Measured: Week 72

  5. Proportion of Participants With Improvement in Each Histologic Feature of NASH by at Least 1 Point as Determined by Liver Biopsy

    Proportion of participants with improvement in each histologic feature of NASH by at least 1 point as determined by liver biopsy at Week 72.

    Measured: Week 72

  6. Proportion of Participants With Improvement of Fibrosis by ≥ 2 Stages by Liver Biopsy

    Proportion of participants with improvement of fibrosis by ≥ 2 stages by liver biopsy.

    Measured: Week 72

  7. Proportion of Participants With Improvement in NAS by at Least 2 Points With no Worsening of Fibrosis as Determined by Liver Biopsy

    Proportion of participants with improvement in NAS by at least 2 points with no worsening of fibrosis as determined by liver biopsy at Week 72.

    Measured: Week 72

  8. Proportion of Participants With Improvement of Fibrosis and Resolution of NASH as a Composite Endpoint as Defined by Both Endpoints Being Met in the Same Participant

    Proportion of participants with improvement of fibrosis and resolution of NASH as a composite endpoint as defined by both endpoints being met in the same participant at week 72.

    Measured: Baseline, Week 72

  9. Proportion of Participants With Resolution of NASH and no Worsening of Liver Fibrosis

    Proportion of participants with resolution of NASH and no worsening of liver fibrosis at Week 72.

    Measured: Week 72

  10. Proportion of Participants With Histological Progression to Cirrhosis as Determined by Liver Biopsy

    Proportion of participants with histological progression to cirrhosis as determined by liver biopsy at Week 72.

    Measured: Week 72

  11. Participants With TEAEs Leading to Discontinuation

    Treatment emergent adverse events (TEAEs) were defined as AEs occurring or worsening on or after the first dose of study drug until the last dose of study drug. TEAEs were regarded as leading to discontinuation if they led to discontinuation of the study drug.

    Measured: Day 1 to Week 72

  12. Percentage Change of Fat in the Liver From Baseline

    Percentage change of fat in the liver as assessed by magnetic resonance imaging proton density fat fraction (MRI PDFF) from Baseline to Week 12.

    Measured: Baseline, Week 12

  13. Change in Liver Stiffness From Baseline

    Change in liver stiffness by magnetic resonance elastography (MRE) in kilopascal (kPa) from Baseline at Week 12.

    Measured: Baseline, Week 12

  14. Change in Triglycerides From Baseline

    Change in Triglycerides from Baseline at Week 12.

    Measured: Baseline, Week 12

  15. Change in Adiponectin From Baseline

    Change in adiponectin from Baseline at Week 12.

    Measured: Baseline, Week 12

  16. Plasma Concentration of EDP-305

    Plasma concentration at second post dose (2-4 hours post dose) at Week 12.

    Measured: 2-4 hours post dose at Week 12

  17. Change in VAS (Visual Analog Score) From Baseline

    Change in VAS from Baseline at Week 12. Change from baseline was analyzed using a restricted maximum likelihood-based MMRM technique. Two separate scales were used to assess pruritus. An itch VAS was used to record the intensity of the pruritus by Furue (Furue et al., 2013). Scale referred to no pruritus (0 point) and the end of the scale to the most severe pruritus (10 points).

    If the VAS score was greater than zero (i.e. itch), a multidimensional 5D-itch scale developed by Elman (Elman et al., 2010) indicated sum of 0-2 = score of 1, sum of 3-5 = score of 2, sum of 6-10 = score of 3, sum of 11-13 = score of 4, and sum of 14-16 = score of 5. It was used to assess five different dimensions of pruritus within the last two weeks. The five dimensions assessed were duration, degree, direction, disability, and distribution. The total 5D itch score was obtained by summing up the five domain scores and ranges between 5 (no pruritus) and 25 (most severe pruritus).

    Measured: Baseline, Week 12

  18. Change in Total Cholesterol From Baseline

    Change in Total Cholesterol from Baseline to Week 12 versus placebo.

    Measured: Baseline, Week 12

  19. Change in HDL From Baseline

    Change in HDL from Baseline at week 12.

    Measured: Baseline, Week 12

  20. Change in LDL From Baseline

    Change in LDL From Baseline to Week 12.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start27 Jan 2020
  3. Primary completion4 Oct 2021
  4. Study completion30 Nov 2021

Why it stopped: Enanta Pharmaceuticals, Inc. made the strategic decision to discontinue the ARGON-2 study to prioritize combination treatment approaches. This decision was not based on safety concerns.

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378010
Sponsor's protocol ID
EDP 305-102
Other IDs
2019-003876-38, 2019
Status last verified
Apr 2023
First submitted
4 May 2020
Last updated
19 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EDP-305 1.5 mg and EDP-305 2 mg in people with Non-Alcoholic Steatohepatitis, run by Enanta Pharmaceuticals, Inc at 81 sites in 6 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 10 inclusion and 35 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, United Kingdom, Germany, Argentina, Canada and 1 more country. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Participants Who Achieve ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis and/or Resolution of Steatohepatitis and no Worsening of Liver Fibrosis as Determined by Liver Biopsy (time frame: Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04378010.

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 19 May 2023.

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