NASH - Nonalcoholic SteatohepatitisPhase 2VOYAGENCT04173065
A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
A Phase 2 study testing VK2809 in people with NASH - Nonalcoholic Steatohepatitis, run by Viking Therapeutics, Inc. at 79 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- VK2809
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 79 sitesin 5 countries
- Study dates
- 15 Nov 2019to 26 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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
Trial locations and contacts
79 sites in 5 countries.
79 sites in 5 countries
United States68 sites
Viking Clinical Site 158
Ann Arbor, Michigan, 48109
Viking Clinical Site 115
Arlington, Texas, 76012
Viking Clinical Site 144
Atlanta, Georgia, 30309
Viking Clinical Site 109
Baltimore, Maryland, 21202
Viking Clinical Site 147
Boston, Massachusetts, 02111
Viking Clinical Site 226
Bradenton, Florida, 34208
Viking Clinical Site 314
Chapel Hill, North Carolina, 27514
Viking Clinical Site 137
Cincinnati, Ohio, 45249
Viking Clinical Site 227
Clarksville, Tennessee, 37040
Viking Clinical Site 126
Concord, North Carolina, 28027
Viking Clinical Site 113
Dallas, Texas, 75203
Viking Clinical Site 133
Detroit, Michigan, 48202
Viking Clinical Site 116
Durham, North Carolina, 27710
Viking Clinical Site 220
Edinburg, Texas, 78539
Viking Clinical Site 161
Fresno, California, 93701
Viking Clinical Site 208
Fresno, California, 93720
Viking Clinical Site 216
Glendale, Arizona, 85306
Viking Clinical Site 107
Greenbelt, Maryland, 20770
Viking Clinical Site 127
Greenville, South Carolina, 29605
Viking Clinical Site 118
Hermitage, Tennessee, 37076
Viking Clinical Site 142
Houston, Texas, 77030
Viking Clinical Site 120
Indianapolis, Indiana, 46202
Viking Clinical Site 213
Jackson, Mississippi, 39216
Viking Clinical Site 112
Kansas City, Missouri, 64111
Viking Clinical Site 217
Kansas City, Missouri, 64131
Viking Clinical Site 302
La Jolla, California, 92037
Viking Clinical Site 150
Lakewood Rch, Florida, 34211
Viking Clinical Site 160
Las Vegas, Nevada, 89106
Viking Clinical Site 105
Madison, Alabama, 35758
Viking Clinical Site 111
Marietta, Georgia, 30060
Viking Clinical Site 146
Marrero, Louisiana, 70072
Viking Clinical Site 106
Miami, Florida, 33014
Viking Clinical Site 301
Miami, Florida, 33136
Viking Clinical Site 310
Miami, Florida, 33136
Viking Clinical Site 221
Miami Lakes, Florida, 33016
Viking Clinical Site 134
Montclair, California, 91736
Viking Clinical Site 153
Morehead City, North Carolina, 28557
Viking Clinical Site 156
New Haven, Connecticut, 06510
Viking Clinical Site 307
New Orleans, Louisiana, 70112
Viking Clinical Site 152
New York, New York, 10033
Viking Clinical Site 304
Newport News, Virginia, 23602
Viking Clinical Site 214
North Little Rock, Arkansas, 72117
Viking Clinical Site 224
Ogden, Utah, 84405
Viking Clinical Site 205
Panorama City, California, 91402
Viking Clinical Site 125
Pasadena, California, 91105
Viking Clinical Site 131
Pensacola, Florida, 32503
Viking Clinical Site 148
Philadelphia, Pennsylvania, 19107
Viking Clinical Site 311
Pittsburgh, Pennsylvania, 15213
Viking Clinical Site 215
Port Orange, Florida, 32127
Viking Clinical Site 223
Reno, Nevada, 89511
Viking Clinical Site 110
Rialto, California, 92377
Viking Clinical Site 209
Richmond, Virginia, 23249
Viking Clinical Site 312
Richmond, Virginia, 23298
Viking Clinical Site 128
Rochester, New York, 14642
Viking Clinical Site 117
Sacramento, California, 95817
Viking Clinical Site 102
San Antonio, Texas, 78215
Viking Clinical Site 101
San Antonio, Texas, 78229
Viking Clinical Site 143
San Antonio, Texas, 78229
Viking Clinical Site 201
San Antonio, Texas, 78229
Viking Clinical Site 121
San Diego, California, 92037
Viking Clinical Site 103
San Francisco, California, 94115
Viking Clinical Site 218
Sarasota, Florida, 34240
Viking Clinical Site 317
Seattle, Washington, 98105
Viking Clinical Site 130
South Bend, Indiana, 46635
Viking Clinical Site 145
Topeka, Kansas, 66606
Viking Clinical Site 159
Tucson, Arizona, 85712
Viking Clinical Site 211
West Des Moines, Iowa, 50265
Viking Clinical Site 166
West Monroe, Louisiana, 71291
France5 sites
Viking Clinical Site 611
Amiens, 80054
Viking Clinical Site 612
Créteil, 94000
Viking Clinical Site 610
Grenoble, 38700
Viking Clinical Site 607
Paris, 75012
Viking Clinical Site 603
Paris, 75013
Mexico3 sites
Viking Clinical Site 401
Acapulco de Juárez, Guerrero, 39670
Viking Clinical Site 421
Mexico City, 06700
Viking Clinical Site 422
Monterrey, Nuevo León, 64000
Belgium2 sites
Viking Clinical Site 503
Brussels, VBR, 3000
Viking Clinical Site 502
Brussels, 1070
About this study
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
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
- Being tested
- VK2809, Placebos
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VK2809Drug
Capsule
PlacebosDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
| 1.0 mg | Experimental | Not described Receives: Drug: VK2809 |
| 2.5mg | Experimental | Not described Receives: Drug: VK2809 |
| 5.0 mg | Experimental | Not described Receives: Drug: VK2809 |
| 10 mg | Experimental | Not described Receives: Drug: VK2809 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
NASH CRN fibrosis score
Proportion of subjects with resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start15 Nov 2019
- Primary completion15 May 2023
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viking Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Mancini, MA, MBA, Study director, Viking Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173065
- Sponsor's protocol ID
- VK2809-202
- Acronym
- VOYAGE
- Status last verified
- Jun 2024
- First submitted
- 20 Nov 2019
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04173065
- Acronym / sponsor ID
- VOYAGE / VK2809-202
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Have a screening MRI-PDFF with ≥ 8% liver fat fraction;
- Male and females be 18 to 75 years of age, inclusive, at screening;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VK2809Capsule | Drug | 1.0 mg, 10 mg, 2.5mg, 5.0 mg |
| PlacebosCapsule | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
NASH CRN fibrosis score
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Mancini, MA, MBA study director
Viking Therapeutics, Inc.
79 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VK2809 in people with NASH - Nonalcoholic Steatohepatitis, run by Viking Therapeutics, Inc. at 79 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, France, Mexico, Belgium, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Fat (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.