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VK2809 for NASH (VOYAGE Trial)

Phase 2
Waitlist Available
Research Sponsored by Viking Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a histologically-confirmed diagnosis of NASH on a liver biopsy performed during screening or within 6 months before screening with NASH CRN fibrosis stage 1 to stage 3 and NAS of ≥4 with specific criteria
Male and females be 18 to 75 years of age, inclusive, at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

VOYAGE Trial Summary

This trial will last for 52 weeks and have different groups of people testing different treatments, all of which are blinded. There will be check-ups every 4 weeks and at the end of the study. There will be an equal number of males and females in every group.

Who is the study for?
This trial is for adults aged 18-75 with a confirmed diagnosis of NASH (a type of liver disease) and certain risk factors like diabetes or obesity. Participants must have had a recent liver biopsy showing specific levels of liver damage and fat, be willing to undergo another biopsy, and not drink excessively. They can't join if they've used weight loss drugs recently, have abnormal thyroid or liver tests, take certain other medications, or have heart issues.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of VK2809 over a year compared to a placebo. It's double-blind so neither participants nor doctors know who gets what treatment. Subjects visit the clinic every four weeks after randomization into one of five groups with equal numbers of men and women, stratified by fibrosis stage and diabetes status.See study design
What are the potential side effects?
While the potential side effects are not listed in this summary, common considerations for trials like this may include gastrointestinal discomforts such as nausea or diarrhea, headaches, fatigue, possible allergic reactions to the drug components among others.

VOYAGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver biopsy confirms I have NASH with specific fibrosis and activity levels.
Select...
I am between 18 and 75 years old.

VOYAGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Liver Fat
Secondary outcome measures
NASH CRN fibrosis score

VOYAGE Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: 5.0 mgExperimental Treatment1 Intervention
Group II: 2.5mgExperimental Treatment1 Intervention
Group III: 10 mgExperimental Treatment1 Intervention
Group IV: 1.0 mgExperimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VK2809
2016
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Viking Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
515 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
59 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Marianne Mancini, MA, MBAStudy DirectorViking Therapeutics, Inc.

Media Library

Placebos Clinical Trial Eligibility Overview. Trial Name: NCT04173065 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo, 1.0 mg, 2.5mg, 5.0 mg, 10 mg
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Placebos Highlights & Side Effects. Trial Name: NCT04173065 — Phase 2
Placebos 2023 Treatment Timeline for Medical Study. Trial Name: NCT04173065 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04173065 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the subjects of this experiment restricted to adults?

"The eligibility requirements for this study say that participants must be aged 18 to 75. Out of the 24 clinical trials currently underway, none are for patients younger than 18 whereas 204 are looking specifically for elderly patients."

Answered by AI

How many participants are involved in this research?

"A total of 337 patients that meet the required inclusion criteria must participate in this clinical trial. Patients can receive treatment from various locations, two of which are Viking Clinical Site 211 in West Des Moines, Iowa and Viking Clinical Site 214 in North Little Rock, Arkansas."

Answered by AI

Has there been previous research on VK2809?

"VK2809 was first studied in 2019 at Viking Clinical Site 144. Since then, there have been 242 completed studies with 1 active trial. A large number of these trials are being conducted out of West Des Moines, Iowa."

Answered by AI

Who would be an ideal candidate for this experiment?

"The research team is looking for 337 participants that have a fatty liver and are between 18-75 years old."

Answered by AI

Is this clinical trial being run in a considerable number of medical clinics across Canada?

"Currently, this study is being conducted at Viking Clinical Site 211 in West Des Moines, Iowa; Viking Clinical Site 214 in North Little Rock, Arkansas; Viking Clinical Site 216 in Glendale, Arizona; and 78 other research sites."

Answered by AI

Is this a new clinical trial?

"VK2809 has been under investigation since 2019 when Viking Therapeutics, Inc. ran the first clinical trial with 337 participants. After successful completion of Phase 2 in 2019, there is only one active study for VK2809 being sponsored by Viking Therapeutics, Inc.."

Answered by AI

Are there still slots available for individuals who wish to participate in this research project?

"That is accurate. The most recent update on clinicaltrials.gov was from October 31st, 2022 and it indicates that the study is still recruiting patients. This research project was initially posted on November 15th, 2019 and it plans to admit 337 total participants across 78 different locations."

Answered by AI

What is the most severe adverse reaction to VK2809?

"As this is a Phase 2 trial, there is some evidence to support VK2809's safety. However, as there is no data backing up the efficacy of VK2809 at this time, it received a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
California
New York
Other
How old are they?
18 - 65
What site did they apply to?
Viking Clinical Site 105
Viking Clinical Site 125
Viking Clinical Site 142
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

I want to get my fatty liver under control. There was a NYC location when I was reading about the trial.
PatientReceived no prior treatments
I am interested in all clinical trials that can help others. I’m hoping to find a medication that will help my fatty liver disease.
PatientReceived no prior treatments
Doctors have never tried to do anythng about my fatter liver except to tell me I have one.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Will I be paid? Is parking available?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
2019. "A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04173065.
All > Fatty Liver Disease > Nash
~46 spots leftby Apr 2025
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