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Completed

NCT Number: NCT04480710

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

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

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Key information

Conditions

NASH - Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Fibrosis Fibrosis, Liver Liver Cirrhosis Liver Diseases NAFLD - Nonalcoholic Fatty Liver Disease Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

FDI Clinical Research, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRV431 75mg

Drug

1 x 75mg softgel capsule

Placebo (1 softgel)

Drug

1 x placebo softgel capsule

CRV431 225mg

Drug

3 x 75mg softgel capsule

Placebo (3 softgels)

Drug

3 x placebo softgel capsule

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hepion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: AMBITION

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2020
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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