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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04173065
Other study ID # VK2809-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 15, 2019
Est. completion date January 26, 2024

Study information

Verified date June 2024
Source Viking Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 248
Est. completion date January 26, 2024
Est. primary completion date May 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. 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; 2. 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: 1. NASH Clinical Research Network (CRN) fibrosis stage 1 to stage 3 and 2. 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 3. Have a screening MRI-PDFF with = 8% liver fat fraction; 4. Male and females be 18 to 75 years of age, inclusive, at screening; Exclusion Criteria: 1. 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 2. 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; 3. 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; 4. TSH outside central laboratory reference range; 5. Free T4 outside central laboratory reference range; 6. Cardiac troponin I (cTnI) and creatine kinase MB isoenzyme (CK-MB) > Upper Limit of Normal (ULN) at screening; 7. Serum albumin < 3.5 g/dL; 8. International normalized ratio (INR) > 1.3; 9. Total bilirubin > 1.2 X ULN (except in presence of Gilbert synd 10. Strong or moderate inhibitors or inducers of CYP3A4 are prohibited during the study period 11. 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


Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Drug:
VK2809
Capsule
Placebos
Capsule

Locations

Country Name City State
Belgium Viking Clinical Site 502 Brussels
Belgium Viking Clinical Site 503 Brussels VBR
France Viking Clinical Site 611 Amiens Cedex 1
France Viking Clinical Site 612 Créteil
France Viking Clinical Site 610 Grenoble
France Viking Clinical Site 603 Paris
France Viking Clinical Site 607 Paris
Mexico Viking Clinical Site 401 Acapulco GRO
Mexico Viking Clinical Site 421 Ciudad de mexico
Mexico Viking Clinical Site 422 Monterrey NLE
Puerto Rico Viking Clinical Site 219 San Juan
United States Viking Clinical Site 158 Ann Arbor Michigan
United States Viking Clinical Site 115 Arlington Texas
United States Viking Clinical Site 144 Atlanta Georgia
United States Viking Clinical Site 109 Baltimore Maryland
United States Viking Clinical Site 147 Boston Massachusetts
United States Viking Clinical Site 226 Bradenton Florida
United States Viking Clinical Site 314 Chapel Hill North Carolina
United States Viking Clinical Site 137 Cincinnati Ohio
United States Viking Clinical Site 227 Clarksville Tennessee
United States Viking Clinical Site 126 Concord North Carolina
United States Viking Clinical Site 113 Dallas Texas
United States Viking Clinical Site 133 Detroit Michigan
United States Viking Clinical Site 116 Durham North Carolina
United States Viking Clinical Site 220 Edinburg Texas
United States Viking Clinical Site 161 Fresno California
United States Viking Clinical Site 208 Fresno California
United States Viking Clinical Site 216 Glendale Arizona
United States Viking Clinical Site 107 Greenbelt Maryland
United States Viking Clinical Site 127 Greenville South Carolina
United States Viking Clinical Site 118 Hermitage Tennessee
United States Viking Clinical Site 142 Houston Texas
United States Viking Clinical Site 120 Indianapolis Indiana
United States Viking Clinical Site 213 Jackson Mississippi
United States Viking Clinical Site 112 Kansas City Missouri
United States Viking Clinical Site 217 Kansas City Missouri
United States Viking Clinical Site 302 La Jolla California
United States Viking Clinical Site 150 Lakewood Ranch Florida
United States Viking Clinical Site 160 Las Vegas Nevada
United States Viking Clinical Site 105 Madison Alabama
United States Viking Clinical Site 111 Marietta Georgia
United States Viking Clinical Site 146 Marrero Louisiana
United States Viking Clinical Site 106 Miami Florida
United States Viking Clinical Site 301 Miami Florida
United States Viking Clinical Site 310 Miami Florida
United States Viking Clinical Site 221 Miami Lakes Florida
United States Viking Clinical Site 134 Montclair California
United States Viking Clinical Site 153 Morehead City North Carolina
United States Viking Clinical Site 156 New Haven Connecticut
United States Viking Clinical Site 307 New Orleans Louisiana
United States Viking Clinical Site 152 New York New York
United States Viking Clinical Site 304 Newport News Virginia
United States Viking Clinical Site 214 North Little Rock Arkansas
United States Viking Clinical Site 224 Ogden Utah
United States Viking Clinical Site 205 Panorama City California
United States Viking Clinical Site 125 Pasadena California
United States Viking Clinical Site 131 Pensacola Florida
United States Viking Clinical Site 148 Philadelphia Pennsylvania
United States Viking Clinical Site 311 Pittsburgh Pennsylvania
United States Viking Clinical Site 215 Port Orange Florida
United States Viking Clinical Site 223 Reno Nevada
United States Viking Clinical Site 110 Rialto California
United States Viking Clinical Site 209 Richmond Virginia
United States Viking Clinical Site 312 Richmond Virginia
United States Viking Clinical Site 128 Rochester New York
United States Viking Clinical Site 117 Sacramento California
United States Viking Clinical Site 101 San Antonio Texas
United States Viking Clinical Site 102 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 121 San Diego California
United States Viking Clinical Site 103 San Francisco California
United States Viking Clinical Site 218 Sarasota Florida
United States Viking Clinical Site 317 Seattle Washington
United States Viking Clinical Site 130 South Bend Indiana
United States Viking Clinical Site 145 Topeka Kansas
United States Viking Clinical Site 159 Tucson Arizona
United States Viking Clinical Site 211 West Des Moines Iowa
United States Viking Clinical Site 166 West Monroe Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Viking Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Mexico,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Liver Fat 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. 12 weeks
Secondary NASH CRN fibrosis score Proportion of subjects with resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score. 52 weeks
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