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

NCT04173065 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: VK2809-202
• Study Type: interventional
• Target: 248
• Locations: 5 countries
• Sites: 79

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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NASH CRN fibrosis score

  52 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Placebos

1.0 mg

EXPERIMENTAL

Drug: VK2809

2.5mg

EXPERIMENTAL

Drug: VK2809

5.0 mg

EXPERIMENTAL

Drug: VK2809

10 mg

EXPERIMENTAL

Drug: VK2809

Interventions

VK2809 DRUG

Capsule

1.0 mg; 10 mg; 2.5mg; 5.0 mg

Placebos DRUG

Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Viking Therapeutics, Inc.: lead

Study Sites (79)

Viking Clinical Site 105

Madison, Alabama, 35758, United States

Location

Viking Clinical Site 216

Glendale, Arizona, 85306, United States

Location

Viking Clinical Site 159

Tucson, Arizona, 85712, United States

Location

Viking Clinical Site 214

North Little Rock, Arkansas, 72117, United States

Location

Viking Clinical Site 161

Fresno, California, 93701, United States

Location

Viking Clinical Site 208

Fresno, California, 93720, United States

Location

Viking Clinical Site 302

La Jolla, California, 92037, United States

Location

Viking Clinical Site 134

Montclair, California, 91736, United States

Location

Viking Clinical Site 205

Panorama City, California, 91402, United States

Location

Viking Clinical Site 125

Pasadena, California, 91105, United States

Location

Viking Clinical Site 110

Rialto, California, 92377, United States

Location

Viking Clinical Site 117

Sacramento, California, 95817, United States

Location

Viking Clinical Site 121

San Diego, California, 92037, United States

Location

Viking Clinical Site 103

San Francisco, California, 94115, United States

Location

Viking Clinical Site 156

New Haven, Connecticut, 06510, United States

Location

Viking Clinical Site 226

Bradenton, Florida, 34208, United States

Location

Viking Clinical Site 150

Lakewood Rch, Florida, 34211, United States

Location

Viking Clinical Site 106

Miami, Florida, 33014, United States

Location

Viking Clinical Site 301

Miami, Florida, 33136, United States

Location

Viking Clinical Site 310

Miami, Florida, 33136, United States

Location

Viking Clinical Site 221

Miami Lakes, Florida, 33016, United States

Location

Viking Clinical Site 131

Pensacola, Florida, 32503, United States

Location

Viking Clinical Site 215

Port Orange, Florida, 32127, United States

Location

Viking Clinical Site 218

Sarasota, Florida, 34240, United States

Location

Viking Clinical Site 144

Atlanta, Georgia, 30309, United States

Location

Viking Clinical Site 111

Marietta, Georgia, 30060, United States

Location

Viking Clinical Site 120

Indianapolis, Indiana, 46202, United States

Location

Viking Clinical Site 130

South Bend, Indiana, 46635, United States

Location

Viking Clinical Site 211

West Des Moines, Iowa, 50265, United States

Location

Viking Clinical Site 145

Topeka, Kansas, 66606, United States

Location

Viking Clinical Site 146

Marrero, Louisiana, 70072, United States

Location

Viking Clinical Site 307

New Orleans, Louisiana, 70112, United States

Location

Viking Clinical Site 166

West Monroe, Louisiana, 71291, United States

Location

Viking Clinical Site 109

Baltimore, Maryland, 21202, United States

Location

Viking Clinical Site 107

Greenbelt, Maryland, 20770, United States

Location

Viking Clinical Site 147

Boston, Massachusetts, 02111, United States

Location

Viking Clinical Site 158

Ann Arbor, Michigan, 48109, United States

Location

Viking Clinical Site 133

Detroit, Michigan, 48202, United States

Location

Viking Clinical Site 213

Jackson, Mississippi, 39216, United States

Location

Viking Clinical Site 112

Kansas City, Missouri, 64111, United States

Location

Viking Clinical Site 217

Kansas City, Missouri, 64131, United States

Location

Viking Clinical Site 160

Las Vegas, Nevada, 89106, United States

Location

Viking Clinical Site 223

Reno, Nevada, 89511, United States

Location

Viking Clinical Site 152

New York, New York, 10033, United States

Location

Viking Clinical Site 128

Rochester, New York, 14642, United States

Location

Viking Clinical Site 314

Chapel Hill, North Carolina, 27514, United States

Location

Viking Clinical Site 126

Concord, North Carolina, 28027, United States

Location

Viking Clinical Site 116

Durham, North Carolina, 27710, United States

Location

Viking Clinical Site 153

Morehead City, North Carolina, 28557, United States

Location

Viking Clinical Site 137

Cincinnati, Ohio, 45249, United States

Location

Viking Clinical Site 148

Philadelphia, Pennsylvania, 19107, United States

Location

Viking Clinical Site 311

Pittsburgh, Pennsylvania, 15213, United States

Location

Viking Clinical Site 127

Greenville, South Carolina, 29605, United States

Location

Viking Clinical Site 227

Clarksville, Tennessee, 37040, United States

Location

Viking Clinical Site 118

Hermitage, Tennessee, 37076, United States

Location

Viking Clinical Site 115

Arlington, Texas, 76012, United States

Location

Viking Clinical Site 113

Dallas, Texas, 75203, United States

Location

Viking Clinical Site 220

Edinburg, Texas, 78539, United States

Location

Viking Clinical Site 142

Houston, Texas, 77030, United States

Location

Viking Clinical Site 102

San Antonio, Texas, 78215, United States

Location

Viking Clinical Site 101

San Antonio, Texas, 78229, United States

Location

Viking Clinical Site 143

San Antonio, Texas, 78229, United States

Location

Viking Clinical Site 201

San Antonio, Texas, 78229, United States

Location

Viking Clinical Site 224

Ogden, Utah, 84405, United States

Location

Viking Clinical Site 304

Newport News, Virginia, 23602, United States

Location

Viking Clinical Site 209

Richmond, Virginia, 23249, United States

Location

Viking Clinical Site 312

Richmond, Virginia, 23298, United States

Location

Viking Clinical Site 317

Seattle, Washington, 98105, United States

Location

Viking Clinical Site 503

Brussels, VBR, 3000, Belgium

Location

Viking Clinical Site 502

Brussels, 1070, Belgium

Location

Viking Clinical Site 611

Amiens, 80054, France

Location

Viking Clinical Site 612

Créteil, 94000, France

Location

Viking Clinical Site 610

Grenoble, 38700, France

Location

Viking Clinical Site 607

Paris, 75012, France

Location

Viking Clinical Site 603

Paris, 75013, France

Location

Viking Clinical Site 401

Acapulco de Juárez, Guerrero, 39670, Mexico

Location

Viking Clinical Site 422

Monterrey, Nuevo León, 64000, Mexico

Location

Viking Clinical Site 421

Mexico City, 06700, Mexico

Location

Viking Clinical Site 219

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

2-((3,5-dimethyl-4-(4'-hydroxy-3'-isopropylbenzyl)phenoxy)methyl)-4-(3-chlorophenyl)-2-oxido(1,3,2)dioxaphosphonane

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Marianne Mancini, MA, MBA

  Viking Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 21, 2019
• Study Start: November 15, 2019
• Primary Completion: May 15, 2023
• Study Completion: January 26, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

FR (5); PR (1); US (68); BE (2); ME (3)