NASH - Nonalcoholic SteatohepatitisPhase 2AMBITIONNCT04480710
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
A Phase 2 study testing CRV431 75mg and CRV431 225mg in people with NASH - Nonalcoholic Steatohepatitis and Fibrosis, Liver, run by Hepion Pharmaceuticals, Inc. at 10 sites in 2 countries.
Trial summary
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, NAFLD - Nonalcoholic Fatty Liver Disease
- What is being tested?
- CRV431 75mg and CRV431 225mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 23 Jun 2020to 30 Oct 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
- 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.
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Aventiv Research Inc.
Columbus, Ohio, 43213
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
La Salud Research, Inc.
Miami, Florida, 33155
Conquest Clinical Research
Orange, California, 92866
Progressive Medical Research
Port Orange, Florida, 32127
Alliance Clinical Research
Poway, California, 92064
Quality Research Inc.
San Antonio, Texas, 78209
Pinnacle Research Group
San Antonio, Texas, 78229
Covenant Research, LLC.
Sarasota, Florida, 34249
About this study
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
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
Read the 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.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, NAFLD - Nonalcoholic Fatty Liver Disease
- Being tested
- CRV431 75mg, Placebo (1 softgel), CRV431 225mg, Placebo (3 softgels)
- Keywords
- Anti-fibrotic
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRV431 75mgDrug
1 x 75mg softgel capsule
Placebo (1 softgel)Drug
1 x placebo softgel capsule
CRV431 225mgDrug
3 x 75mg softgel capsule
Placebo (3 softgels)Drug
3 x placebo softgel capsule
| Study group | Role | What they receive |
|---|---|---|
| CRV431 75mg | Experimental | CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions Receives: Drug: CRV431 75mg |
| Placebo, 75mg | Placebo comparator | Placebo, softgel capsule, QD, 28 days, fasted conditions Receives: Drug: Placebo (1 softgel) |
| CRV431 225mg | Experimental | CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions Receives: Drug: CRV431 225mg |
| Placebo, 225mg | Placebo comparator | CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Receives: Drug: Placebo (3 softgels) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Safety and Tolerability Events of CRV431 Versus Placebo.
Number of adverse events, serious adverse events, and clinical laboratory abnormalities.
Measured: Time from informed consent to study day 42.
Tmax, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Timepoints for data collection include 0, 2.0 hours, 4.0 hours, 8 hours on both Day 1 and Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start23 Jun 2020
- Primary completion29 Jun 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multi-center, single-blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Canizares, R.Ph., Study director, Hepion Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480710
- Sponsor's protocol ID
- HEPA-CRV431-201
- Acronym
- AMBITION
- Status last verified
- Jun 2022
- First submitted
- 9 Jul 2020
- Last updated
- 15 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04480710
- Acronym / sponsor ID
- AMBITION / HEPA-CRV431-201
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, NAFLD - Nonalcoholic Fatty Liver Disease
- Keywords
- Anti-fibrotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hepion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Posted 15 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized, multi-center, single-blind
| Arm | Type | Receives |
|---|---|---|
| CRV431 75mg | Experimental | Drug: CRV431 75mgCRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions |
| Placebo, 75mg | Placebo comparator | Drug: Placebo (1 softgel)Placebo, softgel capsule, QD, 28 days, fasted conditions |
| CRV431 225mg | Experimental | Drug: CRV431 225mgCRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions |
| Placebo, 225mg | Placebo comparator | Drug: Placebo (3 softgels)CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (10 listed)
- 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.
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 |
|---|---|---|
| CRV431 75mg1 x 75mg softgel capsule | Drug | CRV431 75mg |
| Placebo (1 softgel)1 x placebo softgel capsule | Drug | Placebo, 75mg |
| CRV431 225mg3 x 75mg softgel capsule | Drug | CRV431 225mg |
| Placebo (3 softgels)3 x placebo softgel capsule | Drug | Placebo, 225mg |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Carlos Canizares, R.Ph. study director
Hepion Pharmaceuticals, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRV431 75mg and CRV431 225mg in people with NASH - Nonalcoholic Steatohepatitis and Fibrosis, Liver, run by Hepion Pharmaceuticals, Inc. at 10 sites in 2 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Puerto Rico. 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 15 Jul 2022). 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?
Number of Safety and Tolerability Events of CRV431 Versus Placebo. (time frame: Time from informed consent to study day 42.). The study lists 4 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 15 Jul 2022.