A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Drug: VK2809Drug: Placebos
- Registration Number
- NCT04173065
- Lead Sponsor
- Viking Therapeutics, Inc.
- Brief Summary
The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an equal distribution of males and females in each treatment arm. Subjects will be stratified by gender, fibrosis stage, and diabetes status.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 248
-
Provide a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and is willing and able to participate;
-
Have a histologically-confirmed diagnosis of NASH on a liver biopsy performed during screening or within 6 months before screening; for this study, confirmation requires:
- NASH Clinical Research Network (CRN) fibrosis stage 1 to stage 3 and
- NASH activity score (NAS) of ≥4 with at least a score of 1 in each of the following NAS components: ballooning degeneration (score = 0-2), lobular inflammation (score = 0-3) and steatosis (score = 0-3); (c) F1 subjects must have at least one of these risk factors: type 2 diabetes, body mass index of ≥ 30 mg/ m2, and/ or alanine aminotransferase > 1.5 x ULN
-
Have a screening MRI-PDFF with ≥ 8% liver fat fraction;
-
Male and females be 18 to 75 years of age, inclusive, at screening;
- Are unwilling to undergo the required liver biopsy procedures or have any condition that would prevent obtaining a liver biopsy as part of this clinical protocol
- Have evidence of current or history of excessive alcohol consumption of more than 20 g per day for women and 30 g per day for men, on average, within 6 months before the qualifying liver biopsy and up to randomization, or are unable to provide a reliable estimate of alcohol consumption during this period;
- Treatment with medications for the purpose of weight loss within 6 months prior to qualifying liver biopsy, unless approved after consultation with the medical monitor. These include drugs approved for weight loss (e.g. orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as drugs used off-label, herbal preparations and dietary supplements marketed for control of body weight or appetite;
- TSH outside central laboratory reference range;
- Free T4 outside central laboratory reference range;
- Cardiac troponin I (cTnI) and creatine kinase MB isoenzyme (CK-MB) > Upper Limit of Normal (ULN) at screening;
- Serum albumin < 3.5 g/dL;
- International normalized ratio (INR) > 1.3;
- Total bilirubin > 1.2 X ULN (except in presence of Gilbert synd
- Strong or moderate inhibitors or inducers of CYP3A4 are prohibited during the study period
- Drugs that may affect liver fat content or are associated with nonalcoholic fatty liver disease (NAFLD) are prohibited during the 3 month period prior to the baseline liver biopsy and up to the end of treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5.0 mg VK2809 - 10 mg VK2809 - 1.0 mg VK2809 - 2.5mg VK2809 - Placebo Placebos -
- Primary Outcome Measures
Name Time Method Liver Fat 12 weeks Relative change in liver fat content (assessed by MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809 compared to the change in subjects treated with placebo.
- Secondary Outcome Measures
Name Time Method NASH CRN fibrosis score 52 weeks Proportion of subjects with resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score.
Trial Locations
- Locations (79)
Viking Clinical Site 148
🇺🇸Philadelphia, Pennsylvania, United States
Viking Clinical Site 317
🇺🇸Seattle, Washington, United States
Viking Clinical Site 160
🇺🇸Las Vegas, Nevada, United States
Viking Clinical Site 137
🇺🇸Cincinnati, Ohio, United States
Viking Clinical Site 159
🇺🇸Tucson, Arizona, United States
Viking Clinical Site 144
🇺🇸Atlanta, Georgia, United States
Viking Clinical Site 216
🇺🇸Glendale, Arizona, United States
Viking Clinical Site 131
🇺🇸Pensacola, Florida, United States
Viking Clinical Site 118
🇺🇸Hermitage, Tennessee, United States
Viking Clinical Site 301
🇺🇸Miami, Florida, United States
Viking Clinical Site 150
🇺🇸Lakewood Ranch, Florida, United States
Viking Clinical Site 107
🇺🇸Greenbelt, Maryland, United States
Viking Clinical Site 224
🇺🇸Ogden, Utah, United States
Viking Clinical Site 130
🇺🇸South Bend, Indiana, United States
Viking Clinical Site 166
🇺🇸West Monroe, Louisiana, United States
Viking Clinical Site 226
🇺🇸Bradenton, Florida, United States
Viking Clinical Site 221
🇺🇸Miami Lakes, Florida, United States
Viking Clinical Site 111
🇺🇸Marietta, Georgia, United States
Viking Clinical Site 223
🇺🇸Reno, Nevada, United States
Viking Clinical Site 106
🇺🇸Miami, Florida, United States
Viking Clinical Site 211
🇺🇸West Des Moines, Iowa, United States
Viking Clinical Site 128
🇺🇸Rochester, New York, United States
Viking Clinical Site 227
🇺🇸Clarksville, Tennessee, United States
Viking Clinical Site 109
🇺🇸Baltimore, Maryland, United States
Viking Clinical Site 147
🇺🇸Boston, Massachusetts, United States
Viking Clinical Site 120
🇺🇸Indianapolis, Indiana, United States
Viking Clinical Site 421
🇲🇽Ciudad de mexico, Mexico
Viking Clinical Site 153
🇺🇸Morehead City, North Carolina, United States
Viking Clinical Site 127
🇺🇸Greenville, South Carolina, United States
Viking Clinical Site 610
🇫🇷Grenoble, France
Viking Clinical Site 502
🇧🇪Brussels, Belgium
Viking Clinical Site 503
🇧🇪Brussels, VBR, Belgium
Viking Clinical Site 219
🇵🇷San Juan, Puerto Rico
Viking Clinical Site 401
🇲🇽Acapulco, GRO, Mexico
Viking Clinical Site 116
🇺🇸Durham, North Carolina, United States
Viking Clinical Site 102
🇺🇸San Antonio, Texas, United States
Viking Clinical Site 101
🇺🇸San Antonio, Texas, United States
Viking Clinical Site 143
🇺🇸San Antonio, Texas, United States
Viking Clinical Site 201
🇺🇸San Antonio, Texas, United States
Viking Clinical Site 145
🇺🇸Topeka, Kansas, United States
Viking Clinical Site 103
🇺🇸San Francisco, California, United States
Viking Clinical Site 133
🇺🇸Detroit, Michigan, United States
Viking Clinical Site 422
🇲🇽Monterrey, NLE, Mexico
Viking Clinical Site 607
🇫🇷Paris, France
Viking Clinical Site 603
🇫🇷Paris, France
Viking Clinical Site 611
🇫🇷Amiens Cedex 1, France
Viking Clinical Site 215
🇺🇸Port Orange, Florida, United States
Viking Clinical Site 214
🇺🇸North Little Rock, Arkansas, United States
Viking Clinical Site 125
🇺🇸Pasadena, California, United States
Viking Clinical Site 105
🇺🇸Madison, Alabama, United States
Viking Clinical Site 161
🇺🇸Fresno, California, United States
Viking Clinical Site 208
🇺🇸Fresno, California, United States
Viking Clinical Site 302
🇺🇸La Jolla, California, United States
Viking Clinical Site 134
🇺🇸Montclair, California, United States
Viking Clinical Site 110
🇺🇸Rialto, California, United States
Viking Clinical Site 205
🇺🇸Panorama City, California, United States
Viking Clinical Site 121
🇺🇸San Diego, California, United States
Viking Clinical Site 310
🇺🇸Miami, Florida, United States
Viking Clinical Site 218
🇺🇸Sarasota, Florida, United States
Viking Clinical Site 146
🇺🇸Marrero, Louisiana, United States
Viking Clinical Site 213
🇺🇸Jackson, Mississippi, United States
Viking Clinical Site 152
🇺🇸New York, New York, United States
Viking Clinical Site 311
🇺🇸Pittsburgh, Pennsylvania, United States
Viking Clinical Site 115
🇺🇸Arlington, Texas, United States
Viking Clinical Site 220
🇺🇸Edinburg, Texas, United States
Viking Clinical Site 113
🇺🇸Dallas, Texas, United States
Viking Clinical Site 142
🇺🇸Houston, Texas, United States
Viking Clinical Site 304
🇺🇸Newport News, Virginia, United States
Viking Clinical Site 612
🇫🇷Créteil, France
Viking Clinical Site 126
🇺🇸Concord, North Carolina, United States
Viking Clinical Site 156
🇺🇸New Haven, Connecticut, United States
Viking Clinical Site 117
🇺🇸Sacramento, California, United States
Viking Clinical Site 158
🇺🇸Ann Arbor, Michigan, United States
Viking Clinical Site 307
🇺🇸New Orleans, Louisiana, United States
Viking Clinical Site 112
🇺🇸Kansas City, Missouri, United States
Viking Clinical Site 314
🇺🇸Chapel Hill, North Carolina, United States
Viking Clinical Site 217
🇺🇸Kansas City, Missouri, United States
Viking Clinical Site 209
🇺🇸Richmond, Virginia, United States
Viking Clinical Site 312
🇺🇸Richmond, Virginia, United States