A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: Placebos; Drug: VK2809

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marianne Mancini, MA, MBA; Phone Number: 858-704-4660; Email: mmancini@vikingtherapeutics.com
• Study Contact Backup: Name: Rebecca Steele; Phone Number: 858-704-4660; Email: rsteele@vikingtherapeutics.com

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Viking Clinical Site 502
  • VBR
    • Brussels, VBR, Belgium, 3000
      • Viking Clinical Site 503
• France
  • Amiens Cedex 1, France, 80054
    • Viking Clinical Site 611
  • Créteil, France, 94000
    • Viking Clinical Site 612
  • Grenoble, France, 38700
    • Viking Clinical Site 610
  • Paris, France, 75012
    • Viking Clinical Site 607
  • Paris, France, 75013
    • Viking Clinical Site 603
• Mexico
  • Ciudad de mexico, Mexico, 06700
    • Viking Clinical Site 421
  • GRO
    • Acapulco, GRO, Mexico, 39670
      • Viking Clinical Site 401
  • NLE
    • Monterrey, NLE, Mexico, 64000
      • Viking Clinical Site 422
• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Viking Clinical Site 219
• United States
  • Alabama
    • Madison, Alabama, United States, 35758
      • Viking Clinical Site 105
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Viking Clinical Site 216
    • Tucson, Arizona, United States, 85712
      • Viking Clinical Site 159
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Viking Clinical Site 214
  • California
    • Fresno, California, United States, 93701
      • Viking Clinical Site 161
    • Fresno, California, United States, 93720
      • Viking Clinical Site 208
    • La Jolla, California, United States, 92037
      • Viking Clinical Site 302
    • Montclair, California, United States, 91736
      • Viking Clinical Site 134
    • Panorama City, California, United States, 91402
      • Viking Clinical Site 205
    • Pasadena, California, United States, 91105
      • Viking Clinical Site 125
    • Rialto, California, United States, 92377
      • Viking Clinical Site 110
    • Sacramento, California, United States, 95817
      • Viking Clinical Site 117
    • San Diego, California, United States, 92037
      • Viking Clinical Site 121
    • San Francisco, California, United States, 94115
      • Viking Clinical Site 103
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Viking Clinical Site 156
  • Florida
    • Bradenton, Florida, United States, 34208
      • Viking Clinical Site 226
    • Lakewood Ranch, Florida, United States, 34211
      • Viking Clinical Site 150
    • Miami, Florida, United States, 33014
      • Viking Clinical Site 106
    • Miami, Florida, United States, 33136
      • Viking Clinical Site 301
    • Miami, Florida, United States, 33136
      • Viking Clinical Site 310
    • Miami Lakes, Florida, United States, 33016
      • Viking Clinical Site 221
    • Pensacola, Florida, United States, 32503
      • Viking Clinical Site 131
    • Port Orange, Florida, United States, 32127
      • Viking Clinical Site 215
    • Sarasota, Florida, United States, 34240
      • Viking Clinical Site 218
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Viking Clinical Site 144
    • Marietta, Georgia, United States, 30060
      • Viking Clinical Site 111
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Viking Clinical Site 120
    • South Bend, Indiana, United States, 46635
      • Viking Clinical Site 130
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Viking Clinical Site 211
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Viking Clinical Site 145
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Viking Clinical Site 146
    • New Orleans, Louisiana, United States, 70112
      • Viking Clinical Site 307
    • West Monroe, Louisiana, United States, 71291
      • Viking Clinical Site 166
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Viking Clinical Site 109
    • Greenbelt, Maryland, United States, 20770
      • Viking Clinical Site 107
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Viking Clinical Site 147
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Viking Clinical Site 158
    • Detroit, Michigan, United States, 48202
      • Viking Clinical Site 133
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Viking Clinical Site 213
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Viking Clinical Site 112
    • Kansas City, Missouri, United States, 64131
      • Viking Clinical Site 217
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Viking Clinical Site 160
    • Reno, Nevada, United States, 89511
      • Viking Clinical Site 223
  • New York
    • New York, New York, United States, 10033
      • Viking Clinical Site 152
    • Rochester, New York, United States, 14642
      • Viking Clinical Site 128
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Viking Clinical Site 314
    • Concord, North Carolina, United States, 28027
      • Viking Clinical Site 126
    • Durham, North Carolina, United States, 27710
      • Viking Clinical Site 116
    • Morehead City, North Carolina, United States, 28557
      • Viking Clinical Site 153
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Viking Clinical Site 137
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Viking Clinical Site 148
    • Pittsburgh, Pennsylvania, United States, 15213
      • Viking Clinical Site 311
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Viking Clinical Site 127
  • Tennessee
    • Clarksville, Tennessee, United States, 37040
      • Viking Clinical Site 227
    • Hermitage, Tennessee, United States, 37076
      • Viking Clinical Site 118
  • Texas
    • Arlington, Texas, United States, 76012
      • Viking Clinical Site 115
    • Dallas, Texas, United States, 75203
      • Viking Clinical Site 113
    • Edinburg, Texas, United States, 78539
      • Viking Clinical Site 220
    • Houston, Texas, United States, 77030
      • Viking Clinical Site 142
    • San Antonio, Texas, United States, 78215
      • Viking Clinical Site 102
    • San Antonio, Texas, United States, 78229
      • Viking Clinical Site 101
    • San Antonio, Texas, United States, 78229
      • Viking Clinical Site 143
    • San Antonio, Texas, United States, 78229
      • Viking Clinical Site 201
  • Utah
    • Ogden, Utah, United States, 84405
      • Viking Clinical Site 224
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Viking Clinical Site 304
    • Richmond, Virginia, United States, 23249
      • Viking Clinical Site 209
    • Richmond, Virginia, United States, 23298
      • Viking Clinical Site 312
  • Washington
    • Seattle, Washington, United States, 98105
      • Viking Clinical Site 317

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebos; Capsule
Experimental: 10 mg	Drug: VK2809; Capsule
Experimental: 1.0 mg	Drug: VK2809; Capsule
Experimental: 2.5mg	Drug: VK2809; Capsule
Experimental: 5.0 mg	Drug: VK2809; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Viking Therapeutics, Inc.
• Investigators: Study Director: Marianne Mancini, MA, MBA, Viking Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): May 15, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: VK2809-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No