Clinical Trial Details

Trial ID: L0172
Source ID: NCT04929483
Associated Drug: BIO89-100
Title: Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
Acronym: ENLIVEN
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: NASH - Nonalcoholic Steatohepatitis
Interventions: Drug: BIO89-100
Outcome Measures: Proportion of participants with histological resolution of NASH without worsening of fibrosis|Proportion of participants with ???1 stage decrease in fibrosis stage with no worsening of NASH|Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis|Proportion of participants with NASH resolution AND with ???1 stage decrease in fibrosis stage|Absolute and percentage change from baseline in serum triglycerides|Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol|Mean absolute change and percentage change from baseline in Alanine Transaminase (ALT)|Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3)|Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF)|Percentage change from baseline in HbA1c|Absolute and percentage change from baseline in Adiponectin|Steady-state blood level of BIO89-100|Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol|Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol
Sponsor/Collaborators: 89bio, Inc.
Gender: All
Age: 21 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 216
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: June 4, 2021
Completion Date: September 2023
Results First Posted: --
Last Update Posted: January 25, 2022
Locations: 89bio Clinical Study Site, Birmingham, Alabama, United States|89bio Clinical Study Site, Dothan, Alabama, United States|89bio Clinical Study Site, Guntersville, Alabama, United States|89bio Clinical Study Site, Madison, Alabama, United States|89bio Clinical Study Site, Chandler, Arizona, United States|89bio Clinical Study Site, Glendale, Arizona, United States|89bio Clinical Study Site, Peoria, Arizona, 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, Little Rock, Arkansas, United States|89bio Clinical Study Site, Little Rock, Arkansas, United States|89bio Clinical Study Site, Chula Vista, California, United States|89bio Clinical Study Site, Fresno, California, United States|89bio Clinical Study Site, Huntington Park, California, United States|89bio Clinical Study Site, Long Beach, California, United States|89bio Clinical Study Site, Orange, California, United States|89bio Clinical Study Site, Panorama City, California, United States|89bio Clinical Study Site, Rialto, California, United States|89bio Clinical Study Site, San Diego, California, United States|89bio Clinical Study Site, Santa Ana, California, United States|89bio Clinical Study Site, Boynton Beach, Florida, United States|89bio Clinical Study Site, Bradenton, Florida, United States|89bio Clinical Study Site, Miami Lakes, Florida, United States|89bio Clinical Study Site, Miami, Florida, United States|89bio Clinical Study Site, Miami, Florida, United States|89bio Clinical Study Site, Ocala, Florida, United States|89bio Clinical Study Site, Pinellas Park, Florida, United States|89bio Clinical Study Site, Port Orange, Florida, United States|89bio Clinical Study Site, Sandy Springs, Georgia, United States|89bio Clinical Study Site, South Bend, Indiana, United States|89bio Clinical Study Site, Iowa City, Iowa, United States|89bio Clinical Study Site, Kansas City, Kansas, United States|89bio Clinical Study Site, Topeka, Kansas, United States|89bio Clinical Study Site, Marrero, Louisiana, United States|89bio Clinical Study Site, Marrero, Louisiana, United States|89bio Clinical Study Site, Monroe, Louisiana, United States|89bio Clinical Study Site, Shreveport, Louisiana, United States|89bio Clinical Study Site, Greenbelt, Maryland, United States|89bio Clinical Study Site, Saint Louis, Missouri, United States|89bio Clinical Study Site, Las Vegas, Nevada, United States|89bio Clinical Study Site, Las Vegas, Nevada, United States|89bio Clinical Study Site, Florham Park, New Jersey, United States|89bio Clinical Study Site, Concord, North Carolina, United States|89bio Clinical Study Site, Raleigh, North Carolina, United States|89bio Clinical Study Site, Columbus, Ohio, United States|89bio Clinical Study Site, Dayton, Ohio, United States|89bio Clinical Study Site, Springboro, Ohio, United States|89bio Clinical Study Site, Westlake, Ohio, United States|89bio Clinical Study Site, Greenwood, South Carolina, United States|89bio Clinical Study Site, Summerville, South Carolina, United States|89bio Clinical Study Site, Chattanooga, Tennessee, United States|89bio Clinical Study Site, Chattanooga, Tennessee, United States|89bio Clinical Study Site, Hermitage, Tennessee, United States|89bio Clinical Study Site, Austin, Texas, United States|89bio Clinical Study Site, Austin, Texas, United States|89bio Clinical Study Site, Dallas, Texas, United States|89bio Clinical Study Site, Dallas, Texas, United States|89bio Clinical Study Site, Edinburg, Texas, United States|89bio Clinical Study Site, Fort Worth, Texas, United States|89bio Clinical Study Site, Garland, Texas, United States|89bio Clinical Study Site, Houston, Texas, United States|89bio Clinical Study Site, Houston, Texas, United States|89bio Clinical Study Site, Houston, 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, Wichita Falls, Texas, United States|89bio Clinical Study Site, Ogden, Utah, United States|89bio Clinical Study Site, Riverton, Utah, United States|89bio Clinical Study Site, Sandy, Utah, United States|89bio Clinical Study Site, Richmond, Virginia, United States|89bio Clinical Study Site, Richmond, Virginia, United States|89bio Clinical Study Site, Richmond, Virginia, United States|89bio Clinical Study Site, Seattle, Washington, United States|89bio Clinical Study Site, Spokane, Washington, United States|89bio Clinical Study Site, Toronto, Ontario, Canada|89bio Clinical Study Site, San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT04929483

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D040 BIO89-100 Biological drug -- FGF21 analog Improve insulin resistance; Enhance lipid metabolism Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details