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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173065
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Viking Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: VK2809 Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebos
Capsule

Experimental: 1.0 mg Drug: VK2809
Capsule

Experimental: 2.5mg Drug: VK2809
Capsule

Experimental: 5.0 mg Drug: VK2809
Capsule

Experimental: 10 mg Drug: VK2809
Capsule




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173065


Contacts
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Contact: Marianne Mancini, MA, MBA 858-704-4660 mmancini@vikingtherapeutics.com
Contact: Rebecca Steele 858-704-4660 rsteele@vikingtherapeutics.com

Locations
Show Show 65 study locations
Sponsors and Collaborators
Viking Therapeutics, Inc.
Investigators
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Study Director: Marianne Mancini, MA, MBA Viking Therapeutics, Inc.
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Responsible Party: Viking Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04173065    
Other Study ID Numbers: VK2809-202
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases