Clinical trial NCT04173065: A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
Official title: VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Viking Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Liver Fat
timeFrame: 12 weeks
Secondary outcomes:
measure: NASH CRN fibrosis score
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Viking Clinical Site 105
state: Alabama
city: Glendale
country: United States
facility: Viking Clinical Site 216
state: Arizona
city: Tucson
country: United States
facility: Viking Clinical Site 159
state: Arizona
city: North Little Rock
country: United States
facility: Viking Clinical Site 214
state: Arkansas
city: Fresno
country: United States
facility: Viking Clinical Site 161
state: California
city: Fresno
country: United States
facility: Viking Clinical Site 208
state: California
city: La Jolla
country: United States
facility: Viking Clinical Site 302
state: California
city: Montclair
country: United States
facility: Viking Clinical Site 134
state: California
city: Panorama City
country: United States
facility: Viking Clinical Site 205
state: California
city: Pasadena
country: United States
facility: Viking Clinical Site 125
state: California
city: Rialto
country: United States
facility: Viking Clinical Site 110
state: California
city: Sacramento
country: United States
facility: Viking Clinical Site 117
state: California
city: San Diego
country: United States
facility: Viking Clinical Site 121
state: California
city: San Francisco
country: United States
facility: Viking Clinical Site 103
state: California
city: New Haven
country: United States
facility: Viking Clinical Site 156
state: Connecticut
city: Bradenton
country: United States
facility: Viking Clinical Site 226
state: Florida
city: Lakewood Ranch
country: United States
facility: Viking Clinical Site 150
state: Florida
city: Miami Lakes
country: United States
facility: Viking Clinical Site 221
state: Florida
city: Miami
country: United States
facility: Viking Clinical Site 106
state: Florida
city: Miami
country: United States
facility: Viking Clinical Site 301
state: Florida
city: Miami
country: United States
facility: Viking Clinical Site 310
state: Florida
city: Pensacola
country: United States
facility: Viking Clinical Site 131
state: Florida
city: Port Orange
country: United States
facility: Viking Clinical Site 215
state: Florida
city: Sarasota
country: United States
facility: Viking Clinical Site 218
state: Florida
city: Atlanta
country: United States
facility: Viking Clinical Site 144
state: Georgia
city: Marietta
country: United States
facility: Viking Clinical Site 111
state: Georgia
city: Indianapolis
country: United States
facility: Viking Clinical Site 120
state: Indiana
city: South Bend
country: United States
facility: Viking Clinical Site 130
state: Indiana
city: West Des Moines
country: United States
facility: Viking Clinical Site 211
state: Iowa
city: Topeka
country: United States
facility: Viking Clinical Site 145
state: Kansas
city: Marrero
country: United States
facility: Viking Clinical Site 146
state: Louisiana
city: New Orleans
country: United States
facility: Viking Clinical Site 307
state: Louisiana
city: West Monroe
country: United States
facility: Viking Clinical Site 166
state: Louisiana
city: Baltimore
country: United States
facility: Viking Clinical Site 109
state: Maryland
city: Greenbelt
country: United States
facility: Viking Clinical Site 107
state: Maryland
city: Boston
country: United States
facility: Viking Clinical Site 147
state: Massachusetts
city: Ann Arbor
country: United States
facility: Viking Clinical Site 158
state: Michigan
city: Detroit
country: United States
facility: Viking Clinical Site 133
state: Michigan
city: Jackson
country: United States
facility: Viking Clinical Site 213
state: Mississippi
city: Kansas City
country: United States
facility: Viking Clinical Site 112
state: Missouri
city: Kansas City
country: United States
facility: Viking Clinical Site 217
state: Missouri
city: Las Vegas
country: United States
facility: Viking Clinical Site 160
state: Nevada
city: Reno
country: United States
facility: Viking Clinical Site 223
state: Nevada
city: New York
country: United States
facility: Viking Clinical Site 152
state: New York
city: Rochester
country: United States
facility: Viking Clinical Site 128
state: New York
city: Chapel Hill
country: United States
facility: Viking Clinical Site 314
state: North Carolina
city: Concord
country: United States
facility: Viking Clinical Site 126
state: North Carolina
city: Durham
country: United States
facility: Viking Clinical Site 116
state: North Carolina
city: Morehead City
country: United States
facility: Viking Clinical Site 153
state: North Carolina
city: Cincinnati
country: United States
facility: Viking Clinical Site 137
state: Ohio
city: Philadelphia
country: United States
facility: Viking Clinical Site 148
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Viking Clinical Site 311
state: Pennsylvania
city: Greenville
country: United States
facility: Viking Clinical Site 127
state: South Carolina
city: Clarksville
country: United States
facility: Viking Clinical Site 227
state: Tennessee
city: Hermitage
country: United States
facility: Viking Clinical Site 118
state: Tennessee
city: Arlington
country: United States
facility: Viking Clinical Site 115
state: Texas
city: Dallas
country: United States
facility: Viking Clinical Site 113
state: Texas
city: Edinburg
country: United States
facility: Viking Clinical Site 220
state: Texas
city: Houston
country: United States
facility: Viking Clinical Site 142
state: Texas
city: San Antonio
country: United States
facility: Viking Clinical Site 102
state: Texas
city: San Antonio
country: United States
facility: Viking Clinical Site 101
state: Texas
city: San Antonio
country: United States
facility: Viking Clinical Site 143
state: Texas
city: San Antonio
country: United States
facility: Viking Clinical Site 201
state: Texas
city: Ogden
country: United States
facility: Viking Clinical Site 224
state: Utah
city: Newport News
country: United States
facility: Viking Clinical Site 304
state: Virginia
city: Richmond
country: United States
facility: Viking Clinical Site 209
state: Virginia
city: Richmond
country: United States
facility: Viking Clinical Site 312
state: Virginia
city: Seattle
country: United States
facility: Viking Clinical Site 317
state: Washington
city: Brussels
country: Belgium
facility: Viking Clinical Site 503
state: VBR
city: Brussels
country: Belgium
facility: Viking Clinical Site 502
city: Amiens Cedex 1
country: France
facility: Viking Clinical Site 611
city: Créteil
country: France
facility: Viking Clinical Site 612
city: Grenoble
country: France
facility: Viking Clinical Site 610
city: Paris
country: France
facility: Viking Clinical Site 607
city: Paris
country: France
facility: Viking Clinical Site 603
city: Acapulco
country: Mexico
facility: Viking Clinical Site 401
state: GRO
city: Monterrey
country: Mexico
facility: Viking Clinical Site 422
state: NLE
city: Ciudad de mexico
country: Mexico
facility: Viking Clinical Site 421
city: San Juan
country: Puerto Rico
facility: Viking Clinical Site 219
Study officials:
affiliation: Viking Therapeutics, Inc.
name: Marianne Mancini, MA, MBA
role: STUDY_DIRECTOR
References: