NASH - Nonalcoholic Steatohepatitis Clinical Trial
— ENLIVENOfficial title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BIO89-100 in Subjects With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
| Verified date | February 2024 |
| Source | 89bio, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.
| Status | Active, not recruiting |
| Enrollment | 222 |
| Est. completion date | September 2024 |
| Est. primary completion date | February 14, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 75 Years |
| Eligibility | Key Inclusion Criteria: - Age 21 to 75 - Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS =4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. - Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period Key Exclusion Criteria: - Have poorly controlled high blood pressure - Have type 1 diabetes or poorly controlled type 2 diabetes. - History of cirrhosis or evidence of cirrhosis by clinical, imaging or liver biopsy evaluation - Are planning to try to lose weight during the conduct of the study. - Have a BMI <25 kg/m2 Other inclusion and exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | 89bio Clinical Study Site | San Juan | |
| United States | 89bio Clinical Study Site | Athens | Georgia |
| United States | 89bio Clinical Study Site | Austin | Texas |
| United States | 89bio Clinical Study Site | Austin | Texas |
| United States | 89bio Clinical Study Site | Beaumont | Texas |
| United States | 89bio Clinical Study Site | Birmingham | Alabama |
| United States | 89bio Clinical Study Site | Birmingham | Alabama |
| United States | 89bio Clinical Study Site | Boynton Beach | Florida |
| United States | 89bio Clinical Study Site | Bradenton | Florida |
| United States | 89bio Clinical Study Site | Chandler | Arizona |
| United States | 89bio Clinical Study Site | Chattanooga | Tennessee |
| United States | 89bio Clinical Study Site | Chattanooga | Tennessee |
| United States | 89bio Clinical Study Site | Chula Vista | California |
| United States | 89bio Clinical Study Site | Columbus | Ohio |
| United States | 89bio Clinical Study Site | Concord | North Carolina |
| United States | 89bio Clinical Study Site | Dallas | Texas |
| United States | 89bio Clinical Study Site | Dallas | Texas |
| United States | 89bio Clinical Study Site | Dayton | Ohio |
| United States | 89bio Clinical Study Site | Dothan | Alabama |
| United States | 89bio Clinical Study Site | Edinburg | Texas |
| United States | 89bio Clinical Study Site | Englewood | Colorado |
| United States | 89bio Clinical Study Site | Florham Park | New Jersey |
| United States | 89bio Clinical Study Site | Fort Myers | Florida |
| United States | 89bio Clinical Study Site | Fort Worth | Texas |
| United States | 89bio Clinical Study Site | Garland | Texas |
| United States | 89bio Clinical Study Site | Glen Burnie | Maryland |
| United States | 89bio Clinical Study Site | Glendale | Arizona |
| United States | 89bio Clinical Study Site | Greenbelt | Maryland |
| United States | 89bio Clinical Study Site | Greenwood | South Carolina |
| United States | 89bio Clinical Study Site | Guntersville | Alabama |
| United States | 89bio Clinical Study Site | Hermitage | Tennessee |
| United States | 89bio Clinical Study Site | Houston | Texas |
| United States | 89bio Clinical Study Site | Houston | Texas |
| United States | 89bio Clinical Study Site | Huntington Park | California |
| United States | 89bio Clinical Study Site | Iowa City | Iowa |
| United States | 89bio Clinical Study Site | Lakeland | Florida |
| United States | 89bio Clinical Study Site | Las Vegas | Nevada |
| United States | 89bio Clinical Study Site | Las Vegas | Nevada |
| United States | 89bio Clinical Study Site | Little Rock | Arkansas |
| United States | 89bio Clinical Study Site | Little Rock | Arkansas |
| United States | 89bio Clinical Study Site | Long Beach | California |
| United States | 89bio Clinical Study Site | Madison | Alabama |
| United States | 89bio Clinical Study Site | Maitland | Florida |
| United States | 89bio Clinical Study Site | Manassas | Virginia |
| United States | 89bio Clinical Study Site | Marrero | Louisiana |
| United States | 89bio Clinical Study Site | Marrero | Louisiana |
| United States | 89bio Clinical Study Site | Miami | Florida |
| United States | 89bio Clinical Study Site | Miami | Florida |
| United States | 89bio Clinical Study Site | Miami | Florida |
| United States | 89bio Clinical Study Site | Miami Lakes | Florida |
| United States | 89bio Clinical Study Site | Monroe | Louisiana |
| United States | 89bio Clinical Study Site | New Albany | Indiana |
| United States | 89bio Clinical Study Site | New York | New York |
| United States | 89bio Clinical Study Site | Ocala | Florida |
| United States | 89bio Clinical Study Site | Ogden | Utah |
| United States | 89bio Clinical Study Site | Orange | California |
| United States | 89bio Clinical Study Site | Palmetto Bay | Florida |
| United States | 89bio Clinical Study Site | Panorama City | California |
| United States | 89bio Clinical Study Site | Peoria | Arizona |
| United States | 89bio Clinical Study Site | Pinellas Park | Florida |
| United States | 89bio Clinical Study Site | Port Orange | Florida |
| United States | 89bio Clinical Study Site | Rialto | California |
| United States | 89bio Clinical Study Site | Richmond | Virginia |
| United States | 89bio Clinical Study Site | Richmond | Virginia |
| United States | 89bio Clinical Study Site | Roanoke | Virginia |
| United States | 89bio Clinical Study Site | Saint Louis | Missouri |
| United States | 89bio Clinical Study Site | San Antonio | Texas |
| United States | 89bio Clinical Study Site | San Antonio | Texas |
| United States | 89bio Clinical Study Site | San Antonio | Texas |
| United States | 89bio Clinical Study Site | San Antonio | Texas |
| United States | 89bio Clinical Study Site | Sandy | Utah |
| United States | 89bio Clinical Study Site | Sandy Springs | Georgia |
| United States | 89bio Clinical Study Site | Santa Ana | California |
| United States | 89bio Clinical Study Site | Sarasota | Florida |
| United States | 89bio Clinical Study Site | Seattle | Washington |
| United States | 89bio Clinical Study Site | Shreveport | Louisiana |
| United States | 89bio Clinical Study Site | South Bend | Indiana |
| United States | 89bio Clinical Study Site | Spokane | Washington |
| United States | 89bio Clinical Study Site | Springboro | Ohio |
| United States | 89bio Clinical Study Site | Summerville | South Carolina |
| United States | 89bio Clinical Study Site | Topeka | Kansas |
| United States | 89bio Clinical Study Site | Tucson | Arizona |
| United States | 89bio Clinical Study Site | Tucson | Arizona |
| United States | 89bio Clinical Study Site | Tucson | Arizona |
| United States | 89bio Clinical Study Site | Viera | Florida |
| United States | 89bio Clinical Study Site | Waco | Texas |
| United States | 89bio Clinical Study Site | Waco | Texas |
| United States | 89bio Clinical Study Site | Westlake | Ohio |
| United States | 89bio Clinical Study Site | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| 89bio, Inc. |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Main: Proportion of participants with histological resolution of NASH without worsening of fibrosis | 24 Weeks | ||
| Primary | Main: Proportion of participants with =1 stage decrease in fibrosis stage with no worsening of NASH | 24 Weeks | ||
| Secondary | Main: Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis | 24 Weeks | ||
| Secondary | Main: Proportion of participants with NASH resolution AND with =1 stage decrease in fibrosis stage | 24 Weeks | ||
| Secondary | Main: Proportion of participants with at least a 2-point improvement in NAS and are MRI-PDFF responders AND ALT responders | 24 Weeks | ||
| Secondary | Main: Absolute and percentage change from baseline in serum triglycerides | 12 Weeks, 24 Weeks | ||
| Secondary | Main: Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol | 12 Weeks, 24 Weeks | ||
| Secondary | Main: Absolute change and percentage change from baseline in Alanine Transaminase (ALT) | 12 Weeks, 24 Weeks, 48 Weeks | ||
| Secondary | Main: Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3) | 12 Weeks, 24 Weeks, 48 Weeks | ||
| Secondary | Main: Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF) | 12 Weeks, 24 Weeks, 48 Weeks | ||
| Secondary | Main: Percentage change from baseline in HbA1c | 12 Weeks, 24 Weeks | ||
| Secondary | Main: Absolute and percentage change from baseline in Adiponectin | 12 Weeks, 24 Weeks | ||
| Secondary | Main: Steady-state blood level of BIO89-100 | Plasma trough concentration (ng/mL) of BIO89-100 taken at pre-dose samples | Blood samples for PK analysis collected at up to 8 study visits over the course of approximately 48 weeks | |
| Secondary | Main: Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol | 12 Weeks, 24 Weeks | ||
| Secondary | Main: Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol | 12 Weeks, 24 Weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
| Active, not recruiting |
NCT05479721 -
LITMUS Imaging Study
|
||
| Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
| Recruiting |
NCT04976283 -
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
|
Phase 4 | |
| Completed |
NCT02784444 -
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
|
Phase 2 | |
| Not yet recruiting |
NCT05499949 -
The Franciscus Obesity NASH Study
|
||
| Completed |
NCT04321343 -
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 2 | |
| Recruiting |
NCT04371042 -
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
|
||
| Not yet recruiting |
NCT03648554 -
Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)
|
Phase 4 | |
| Completed |
NCT04972396 -
ALT-801 DDI Study in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT03748628 -
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
|
Phase 1 | |
| Enrolling by invitation |
NCT05195944 -
Semaglutide vs Sitagliptin
|
Phase 4 | |
| Completed |
NCT04643795 -
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
|
Phase 1 | |
| Terminated |
NCT03669133 -
Vitamin E for NASH Treatment in HIV Infected Individuals
|
Phase 2 | |
| Completed |
NCT04066400 -
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
|
N/A | |
| Completed |
NCT03536650 -
Effect of DMR in the Treatment of NASH
|
N/A | |
| Completed |
NCT03783897 -
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects
|
Phase 1 | |
| Completed |
NCT04618744 -
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 2 | |
| Active, not recruiting |
NCT05338034 -
Phase 2a Study of HPG1860 in Subjects With NASH
|
Phase 2 | |
| Active, not recruiting |
NCT04653103 -
NASH in Subjects With Different Classes of Obesity
|