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

June 12, 2024 updated by: Viking Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Liver Fat
Time Frame: 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NASH CRN fibrosis score
Time Frame: 52 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Viking Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marianne Mancini, MA, MBA, Viking Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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