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A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects (AMBITION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480710
Recruitment Status : Completed
First Posted : July 21, 2020
Results First Posted : July 15, 2022
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
Hepion Pharmaceuticals, Inc.

Study Description
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Brief Summary:
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Fibrosis, Liver NAFLD - Nonalcoholic Fatty Liver Disease Drug: CRV431 75mg Drug: Placebo (1 softgel) Drug: CRV431 225mg Drug: Placebo (3 softgels) Phase 2

Detailed Description:
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects. Study will evaluate the safety and tolerability of a once daily 75mg dose and 225mg of CRV431 compared to placebo over 28 days of dosing. Pharmacokinetic parameters of CRV431 and its major metabolites and fraction unbound will also be evaluated. Non-invasive antifibrotic bio-markers will be collected and quantified from presumed NASH F2/F3 subjects dosed with 75mg CRV431 or placebo.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, multi-center, single-blind
Masking: Single (Participant)
Masking Description: placebo-controlled
Primary Purpose: Treatment
Official Title: AMBITION: A Phase 2A, Multiple-Center, Single-Blind, Placebo-Controlled Study To Evaluate The Safety and Tolerability of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
Actual Study Start Date : June 23, 2020
Actual Primary Completion Date : June 29, 2021
Actual Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CRV431 75mg
CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions
 Drug: CRV431 75mg
1 x 75mg softgel capsule
Placebo Comparator: Placebo, 75mg
Placebo, softgel capsule, QD, 28 days, fasted conditions
 Drug: Placebo (1 softgel)
1 x placebo softgel capsule
Experimental: CRV431 225mg
CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions
 Drug: CRV431 225mg
3 x 75mg softgel capsule
Placebo Comparator: Placebo, 225mg
CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions
 Drug: Placebo (3 softgels)
3 x placebo softgel capsule


Outcome Measures
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Primary Outcome Measures :
  1. Number of Safety and Tolerability Events of CRV431 Versus Placebo. [ Time Frame: Time from informed consent to study day 42. ]
    Number of adverse events, serious adverse events, and clinical laboratory abnormalities.

  2. Tmax, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. [ Time Frame: Day 1 and Day 28 ]
    The Tmax value is defined as time to reach maximum whole blood concentration. Each value is a median for the cohort along with the standard deviation presented in hours for Day 1 and Day 28.

  3. Cmax, of Once Daily (QD) 75mg and 22mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. [ Time Frame: Day 1 and Day 28 ]
    The Cmax value is defined as the maximum whole blood concentration presented as ng/mL. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28.

  4. AUC 0-last, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 in Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. [ Time Frame: Timepoints for data collection include 0, 2.0 hours, 4.0 hours, 8 hours on both Day 1 and Day 28. ]
    The AUC 0-last value is defined as the area under the whole blood concentration time curve from time 0 to the time of the last measurable concentration. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female between 18 and 75 years of age (inclusive).
  • Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.
  • Presumed F2/F3 NASH to include: AST >20 IU/L, Pro-C3 >15.5 ng/mL, enhanced liver fibrosis (ELF) score >9.8, and FibroScan >8.5 kPa values.

Key Exclusion Criteria:

  • Pregnant or breastfeeding or planning to become pregnant during the study period.
  • Known allergy to CRV431, cyclosporine, or any of their inactive ingredients.
  • Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus antibodies (HIVAb).
  • Well documented causes of chronic liver disease according to standard diagnostic procedures to include any history or presence of decompensated cirrhosis.
  • Subjects with a platelet count <150,000/mL.
  • Subjects with hemoglobin A1c(HbA1c) >9.5%.
  • Weight loss of more than 5% within 3 months prior to randomization.
  • Subjects with a blood pressure to include a systolic pressure >150 or a diastolic pressure >90.
  • At Screening, an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 mL (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] method) and/or a Kidney Disease Improving Global Outcomes (KDIGO) category of >G2.
  • Subjects with a history of organ transplantation. Corneal transplantation will be allowed.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480710


Locations
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United States, California
Conquest Clinical Research
Orange, California, United States, 92866
Alliance Clinical Research
Poway, California, United States, 92064
United States, Florida
La Salud Research, Inc.
Miami, Florida, United States, 33155
Progressive Medical Research
Port Orange, Florida, United States, 32127
Covenant Research, LLC.
Sarasota, Florida, United States, 34249
United States, Georgia
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States, 30060
United States, Ohio
Aventiv Research Inc.
Columbus, Ohio, United States, 43213
United States, Texas
Quality Research Inc.
San Antonio, Texas, United States, 78209
Pinnacle Research Group
San Antonio, Texas, United States, 78229
Puerto Rico
FDI Clinical Research
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Hepion Pharmaceuticals, Inc.
Investigators
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Study Director: Carlos Canizares, R.Ph. Hepion Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Hepion Pharmaceuticals, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2021

More Information
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Responsible Party: Hepion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04480710    
Other Study ID Numbers: HEPA-CRV431-201
First Posted: July 21, 2020    Key Record Dates
Results First Posted: July 15, 2022
Last Update Posted: July 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hepion Pharmaceuticals, Inc.:
Anti-fibrotic
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
 Fibrosis
Pathologic Processes
Digestive System Diseases