Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
|
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: NCT03812029 |
|
Recruitment Status :
Completed
First Posted : January 22, 2019
Last Update Posted : September 20, 2021
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-alcoholic Steatohepatitis | Drug: EYP001a Other: Placebo | Phase 2 |
This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate the safety and efficacy of EYP001 in patients with NASH who likely have stage F2 to F3 fibrosis at approximately 50 global clinical sites. Overall, approximately 114 eligible patients will be enrolled: 24 patients in Part A (Safety Run-in Cohort), followed by 90 patients in Part B.
In Part A, 24 patients will be randomized on Day 1 to 1 of 4 parallel treatment groups: 100 mg EYP001a twice daily (BID), 200 mg EYP001a once daily (QD), 400 mg EYP001a QD, or placebo BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment groups: 100 mg EYP001a QD, 200 mg EYP001a QD, or placebo QD.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Parallel assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis |
| Actual Study Start Date : | January 30, 2019 |
| Actual Primary Completion Date : | June 6, 2021 |
| Actual Study Completion Date : | July 6, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: EYP001a 100 mg BID
Oral dose twice daily for 12 weeks (84 days)
|
Drug: EYP001a
Oral tablets |
|
Experimental: EYP001a 200 mg QD
Oral dose once daily for 12 weeks (84 days)
|
Drug: EYP001a
Oral tablets |
|
Experimental: EYP001a 400 mg QD
Oral dose once daily for 12 weeks (84 days)
|
Drug: EYP001a
Oral tablets |
|
Placebo Comparator: Placebo
Oral dose twice daily for 12 weeks (84 days)
|
Other: Placebo
Oral tablets |
|
Experimental: EYP001a 100 mg QD
Oral dose once daily for 12 weeks (84 days)
|
Drug: EYP001a
Oral tablets |
- Change in absolute liver fat content as measured by MRI from Baseline to Week 12 [ Time Frame: 12 weeks ]
- Safety profile of EYP001a - Frequency of adverse events [ Time Frame: 12 weeks ]Frequency of adverse events
- % patients with relative reduction in liver fat ≥30% using MRI [ Time Frame: 12 weeks ]
- relative reduction in liver fat [ Time Frame: 12 weeks ]
- Percent change in liver imaging-derived mean iron-corrected T1 [ Time Frame: 12 weeks ]
- Liver inflammation markers [ Time Frame: 12 weeks ]Plasma concentration ALT and AST, ProC3, fibronectin, hyaluronic acid.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent
- Suspected diagnosis of NASH, evidenced by elevated alanine aminotransferase (ALT), liver stiffness compatible with F2 or F3 fibrosis and LFC ≥10% as measured by MRI
- Women of childbearing potential and male patients with female partners must agree to use a dual method of contraception
Exclusion Criteria:
- Evidence of worsening liver injury
- Previous diagnosis of other forms of non-NASH liver disease
- Use of Vitamin E, glitazones, glucagon-like Peptide-1 receptor agonists, ursodeoxycholic acid, or obeticholic acid within 90 days prior to screening
- History of cirrhosis or liver decompensation
- Known history of alcohol abuse or daily heavy alcohol consumption
- Pregnant or breastfeeding women
- Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus
- Patients with contraindications to MRI imaging
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): NCT03812029
Show 42 study locations
| Principal Investigator: | Harrison Stephen, MD | Pinnacle Clinical Research |
| Responsible Party: | Enyo Pharma |
| ClinicalTrials.gov Identifier: | NCT03812029 |
| Other Study ID Numbers: |
EYP001-202 2018-003119-22 ( EudraCT Number ) |
| First Posted: | January 22, 2019 Key Record Dates |
| Last Update Posted: | September 20, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
EYP001 Liver Diseases Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis NASH |
|
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases |