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

NCT ID: NCT04173065

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2024-01-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Capsule

1.0 mg

Group Type: EXPERIMENTAL

VK2809

Intervention Type: DRUG

Capsule

2.5mg

Group Type: EXPERIMENTAL

VK2809

Intervention Type: DRUG

Capsule

5.0 mg

Group Type: EXPERIMENTAL

VK2809

Intervention Type: DRUG

Capsule

10 mg

Group Type: EXPERIMENTAL

VK2809

Intervention Type: DRUG

Capsule

Interventions

VK2809

Capsule

Intervention Type: DRUG

Placebos

Capsule

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viking Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Mancini, MA, MBA

Role: STUDY_DIRECTOR

Viking Therapeutics, Inc.

Locations

Viking Clinical Site 105

Madison, Alabama, United States

Viking Clinical Site 216

Glendale, Arizona, United States

Viking Clinical Site 159

Tucson, Arizona, United States

Viking Clinical Site 214

North Little Rock, Arkansas, 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 205

Panorama City, California, United States

Viking Clinical Site 125

Pasadena, California, United States

Viking Clinical Site 110

Rialto, California, United States

Viking Clinical Site 117

Sacramento, California, United States

Viking Clinical Site 121

San Diego, California, United States

Viking Clinical Site 103

San Francisco, California, United States

Viking Clinical Site 156

New Haven, Connecticut, United States

Viking Clinical Site 226

Bradenton, Florida, United States

Viking Clinical Site 150

Lakewood Rch, Florida, 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 131

Pensacola, Florida, United States

Viking Clinical Site 215

Port Orange, Florida, United States

Viking Clinical Site 218

Sarasota, Florida, United States

Viking Clinical Site 144

Atlanta, Georgia, United States

Viking Clinical Site 111

Marietta, Georgia, United States

Viking Clinical Site 120

Indianapolis, Indiana, United States

Viking Clinical Site 130

South Bend, Indiana, United States

Viking Clinical Site 211

West Des Moines, Iowa, United States

Viking Clinical Site 145

Topeka, Kansas, United States

Viking Clinical Site 146

Marrero, Louisiana, United States

Viking Clinical Site 307

New Orleans, Louisiana, United States

Viking Clinical Site 166

West Monroe, Louisiana, United States

Viking Clinical Site 109

Baltimore, Maryland, United States

Viking Clinical Site 107

Greenbelt, Maryland, United States

Viking Clinical Site 147

Boston, Massachusetts, United States

Viking Clinical Site 158

Ann Arbor, Michigan, United States

Viking Clinical Site 133

Detroit, Michigan, 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 160

Las Vegas, Nevada, United States

Viking Clinical Site 223

Reno, Nevada, United States

Viking Clinical Site 152

New York, New York, United States

Viking Clinical Site 128

Rochester, New York, United States

Viking Clinical Site 314

Chapel Hill, North Carolina, United States

Viking Clinical Site 126

Concord, North Carolina, United States

Viking Clinical Site 116

Durham, North Carolina, United States

Viking Clinical Site 153

Morehead City, North Carolina, United States

Viking Clinical Site 137

Cincinnati, Ohio, United States

Viking Clinical Site 148

Philadelphia, Pennsylvania, United States

Viking Clinical Site 311

Pittsburgh, Pennsylvania, United States

Viking Clinical Site 127

Greenville, South Carolina, United States

Viking Clinical Site 227

Clarksville, Tennessee, United States

Viking Clinical Site 118

Hermitage, Tennessee, United States

Viking Clinical Site 115

Arlington, Texas, United States

Viking Clinical Site 113

Dallas, Texas, United States

Viking Clinical Site 220

Edinburg, Texas, United States

Viking Clinical Site 142

Houston, Texas, 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 224

Ogden, Utah, United States

Viking Clinical Site 304

Newport News, Virginia, United States

Viking Clinical Site 209

Richmond, Virginia, United States

Viking Clinical Site 312

Richmond, Virginia, United States

Viking Clinical Site 317

Seattle, Washington, United States

Viking Clinical Site 503

Brussels, VBR, Belgium

Viking Clinical Site 502

Brussels, , Belgium

Viking Clinical Site 611

Amiens, , France

Viking Clinical Site 612

Créteil, , France

Viking Clinical Site 610

Grenoble, , France

Viking Clinical Site 607

Paris, , France

Viking Clinical Site 603

Paris, , France

Viking Clinical Site 401

Acapulco de Juárez, Guerrero, Mexico

Viking Clinical Site 422

Monterrey, Nuevo León, Mexico

Viking Clinical Site 421

Mexico City, , Mexico

Viking Clinical Site 219

San Juan, , Puerto Rico

Countries

United States; Belgium; France; Mexico; Puerto Rico

Other Identifiers

VK2809-202

Identifier Type: -

Identifier Source: org_study_id