HyperlipidemiaPhase 2NCT02927184
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
A Phase 2 study testing VK2809 in people with Hyperlipidemia and NAFLD, run by Viking Therapeutics, Inc. at 19 sites in United States.
Trial summary
This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemia, NAFLD
- 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
- 59 participants
- Where
- 19 sitesUnited States
- Study dates
- 28 Sep 2016to 26 Mar 2019
- 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
- Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction
- Fasting serum LDL-C >130 mg/dL at screening, >110 mg/dL on lipid lowering medications
- Any one of the following:
- Triglycerides ≥150 mg/dL or receiving prescription medication for elevated triglycerides.
- Systolic blood pressure >130 mmHg or diastolic blood pressure ≥85 mmHg or receiving prescription medication for hypertension.
- Waist circumference >40 inches (men) or >35 inches (women)
- Body mass index (BMI) 18.50 - 40.00 kg/m2 inclusive at screening
- Provide a personally-signed and dated informed consent document
Who cannot join
- Females of childbearing potential and males unwilling to use barrier birth control method (condom) throughout the study
- Resting 12-lead ECG showing QTc >450 msec, any tachyarrhythmia or morphology change, or any other clinically significant abnormality
- Cardiovascular event requiring hospitalization in the past year
- History or presence of thyroid disorder
- History of malignancy in past 5 years
- LDL-C ≥190 mg/dL or familial hypercholesterolemia
- Significant hepatic or renal function test abnormalities
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Avant Research
Beaumont, Texas, 77702
Radiant Research, Inc.
Chandler, Arizona, 85224
Avant Research Associates, LLC
Crowley, Louisiana, 70526
Flint Clinical Research, PLLC
Flint, Michigan, 48503
SC Clinical Research
Garden Grove, California, 92844
Mid Hudson Medical
Hopewell Junction, New York, 12533
ACTCA
Los Angeles, California
Research Institute of South Florida
Miami, Florida, 33173
Research Institute of South Florida
Miami, Florida
Catalina Research Institute
Montclair, California, 91763
HCI- MetroMedic Walk-in
New Bedford, Massachusetts, 02740
HCI- MetroMedic Walk-in
New Bedford, Massachusetts
North America Research, Inc
Pomona, California, 91767
Wake Research Associcates, LLC.
Raleigh, North Carolina, 27612
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Clinical Trials of Texas, INC
San Antonio, Texas, 78229
Radiant Research, Inc.
San Antonio, Texas, 78229
CHEAR Center, LLC
The Bronx, New York, 10459
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess The Efficacy, Safety, and Tolerability of VK2809 Administered for 12 Weeks Followed by a 4-Week Off-Drug Phase in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (PK) measurements.
- Conditions
- Hyperlipidemia, NAFLD
- Being tested
- VK2809, Placebo
- Medical subject headings
- Hyperlipidemias, 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo |
| VK2809 (5mg) | Experimental | 5mg VK2809 capsule Receives: Drug: VK2809 |
| VK2809 (10mg) | Experimental | 10mg VK2809 capsule Receives: Drug: VK2809 |
| VK2809 (10mg QOD) | Experimental | 10mg VK2809 capsule Receives: Drug: VK2809 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-C in patients receiving VK2809 compared to placebo
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start28 Sep 2016
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viking Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Mancini, Study director, Viking Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927184
- Sponsor's protocol ID
- VK2809-201
- Status last verified
- Apr 2021
- First submitted
- 5 Oct 2016
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess The Efficacy, Safety, and Tolerability of VK2809 Administered for 12 Weeks Followed by a 4-Week Off-Drug Phase in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02927184
- Acronym / sponsor ID
- VK2809-201
- Conditions
- Hyperlipidemia, NAFLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (PK) measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule |
| VK2809 (5mg) | Experimental | Drug: VK28095mg VK2809 capsule |
| VK2809 (10mg) | Experimental | Drug: VK280910mg VK2809 capsule |
| VK2809 (10mg QOD) | Experimental | Drug: VK280910mg VK2809 capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction
- Fasting serum LDL-C >130 mg/dL at screening, >110 mg/dL on lipid lowering medications
- Any one of the following:
- Body mass index (BMI) 18.50 - 40.00 kg/m2 inclusive at screening
- Provide a personally-signed and dated informed consent document
Key exclusion criteria (7 listed)
- Females of childbearing potential and males unwilling to use barrier birth control method (condom) throughout the study
- Resting 12-lead ECG showing QTc >450 msec, any tachyarrhythmia or morphology change, or any other clinically significant abnormality
- Cardiovascular event requiring hospitalization in the past year
- History or presence of thyroid disorder
- History of malignancy in past 5 years
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 |
|---|---|---|
| VK2809 | Drug | VK2809 (10mg QOD), VK2809 (10mg), VK2809 (5mg) |
| Placebo | Drug | Placebo |
Primary outcome
Change in LDL-C in patients receiving VK2809 compared to placebo
Time frame: 12 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 26 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
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 study director
Viking Therapeutics, Inc.
19 sites in 1 country: 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 Hyperlipidemia and NAFLD, run by Viking Therapeutics, Inc. at 19 sites in United States.
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 8 inclusion and 7 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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
Change in LDL-C in patients receiving VK2809 compared to placebo (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 26 Apr 2021.