A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects (AMBITION)
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|ClinicalTrials.gov Identifier: NCT04480710|
Recruitment Status : Completed
First Posted : July 21, 2020
Results First Posted : July 15, 2022
Last Update Posted : July 15, 2022
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, multi-center, single-blind|
|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|
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
- 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.
- 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.
- 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.
- 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.
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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|
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.
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
|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|
|FDI Clinical Research|
|San Juan, Puerto Rico, 00927|
|Study Director:||Carlos Canizares, R.Ph.||Hepion Pharmaceuticals, Inc.|
Documents provided by Hepion Pharmaceuticals, Inc.:
|Responsible Party:||Hepion Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Non-alcoholic Fatty Liver Disease
Digestive System Diseases