Severe HypertriglyceridemiaPhase 3AMPLIFYNCT04662528
Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL
A Phase 3 study testing MAT9001 (omega-3 pentaenoic acid) in people with Severe Hypertriglyceridemia, run by Matinas Biopharma, Inc.
Trial summary
To determine the efficacy of MAT9001 compared to placebo in lowering fasting triglyceride levels in subjects with very high fasting triglyceride levels ≥ 500 and < 2000 mg/dL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Hypertriglyceridemia
- What is being tested?
- MAT9001 (omega-3 pentaenoic acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Oct 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting triglycerides ≥500 mg/dL and <2000 mg/dL
- Stable lipid-altering drug therapies permitted
- Stable PCSK9 inhibitor use permitted
- BMI ≥20.0 kg/m2
- Willing to maintain a Therapeutic Life Change diet for the duration of the study
- willing to maintain usual physical activity level for the duration of the study
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- willing to abstain from alcohol consumption for at least 24 hours prior to each study visit
- agrees not to consume more than 2 meals/week containing fish or seafood
- no plans to change smoking/vaping habits or other nicotine use during the study period
- to be in generally good health on the basis of medical history, physical exam, electrocardiogram (ECG), and screening measurements
Who cannot join
- Laboratory test result of clinical significance based on the judgment of the Principal Investigator
- A clinically significant GI, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder
- Known lipoprotein lipase impairment or deficiency or Apo C2 deficiency or familial dysbetalipoproteinemia
- Acute or chronic pancreatitis
- Symptomatic gallstone disease (unless previously treated with cholecystectomy).
- Known nephrotic syndrome
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- Malabsorption syndrome and/or chronic diarrhea
- Previous bariatric surgery or weight change >3 kg (6.6 lb) during the lead in period.
- Diagnosed hereditary or acquired myopathy
- Uncontrolled diabetes (HbA1c ≥9.5%)
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
- Uncontrolled hypothyroidism, thyroid stimulating hormone >5 mIU/L
- History of cancer in the prior 2 years, except non melanoma skin cancer or carcinoma in situ of the cervix
- History of human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Active systemic infection.
- History of paroxysmal atrial fibrillation, persistent atrial fibrillation, and/or history of ventricular tachycardic arrythmia (e.g., ventricular tachycardia/fibrillation)
- History of a bleeding disorder
- Use of omega 3 drugs /supplements /fortified foods
- Use of bile acid sequestrants, fibrates, or niacin
- Use of dietary supplement(s) that alters lipid metabolism
- Use of weight management drug therapy
- Cardiovascular disease event (myocardial infarction or other acute coronary syndrome, stroke, transient ischemic attack), revascularization procedure
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period
- Known allergy or sensitivity to any ingredients in the study products, including fish, seafood or omega 3 fatty acids
- Been exposed to any investigational drug product within 30 days
- Current or recent history or strong potential for illicit drug or excessive alcohol intake
- A condition that would interfere with ability to provide informed consent or comply with the study protocol, or put the person at undue risk
About this study
Official title: A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial
To determine the efficacy of MAT9001 compared to placebo in lowering fasting triglyceride levels in subjects with very high fasting triglyceride levels ≥ 500 and < 2000 mg/dL.
Read the detailed description
This will be a 12-week, randomized, double blind, placebo-controlled safety and efficacy study in men and women ≥18 years of age with fasting triglycerides ≥500 mg/dL and <2000 mg/dL while following a Therapeutic Lifestyle changes (TLC) diet.
- Conditions
- Severe Hypertriglyceridemia
- Being tested
- Placebo, MAT9001 (omega-3 pentaenoic acid)
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
4 x 1g capsules/day
MAT9001 (omega-3 pentaenoic acid)Drug
4 x 1g capsules/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| MAT9001 (omega-3-pentaenoic acid) | Experimental | Not described Receives: Drug: MAT9001 (omega-3 pentaenoic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change from baseline to end of study for MAT9001 versus Placebo
Difference between MAT9001 and placebo treatment groups in triglyceride lowering effect
Measured: 12 weeks
Secondary outcomes (1)
The percent change from baseline to end of study for lipids and lipid biomarkers for MAT9001 versus Placebo
Difference between MAT9001 and placebo treatment groups in other lipid and biomarker levels
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 posted10 Dec 2020
- Study startJun 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe HypertriglyceridemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matinas Biopharma, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Judith Johnson, Study director, Matinas BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662528
- Sponsor's protocol ID
- MAT-003
- Acronym
- AMPLIFY
- Status last verified
- Sep 2021
- First submitted
- 4 Dec 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial
- ClinicalTrials.gov ID
- NCT04662528
- Acronym / sponsor ID
- AMPLIFY / MAT-003
- Conditions
- Severe Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: suspended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Matinas Biopharma, IncIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Jun 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 10 Dec 2020 (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.
To determine the efficacy of MAT9001 compared to placebo in lowering fasting triglyceride levels in subjects with very high fasting triglyceride levels ≥ 500 and < 2000 mg/dL.
Detailed description
This will be a 12-week, randomized, double blind, placebo-controlled safety and efficacy study in men and women ≥18 years of age with fasting triglycerides ≥500 mg/dL and <2000 mg/dL while following a Therapeutic Lifestyle changes (TLC) diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| MAT9001 (omega-3-pentaenoic acid) | Experimental | Drug: MAT9001 (omega-3 pentaenoic acid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Fasting triglycerides ≥500 mg/dL and <2000 mg/dL
- Stable lipid-altering drug therapies permitted
- Stable PCSK9 inhibitor use permitted
- BMI ≥20.0 kg/m2
- Willing to maintain a Therapeutic Life Change diet for the duration of the study
Key exclusion criteria (27 listed)
- Laboratory test result of clinical significance based on the judgment of the Principal Investigator
- A clinically significant GI, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder
- Known lipoprotein lipase impairment or deficiency or Apo C2 deficiency or familial dysbetalipoproteinemia
- Acute or chronic pancreatitis
- Symptomatic gallstone disease (unless previously treated with cholecystectomy).
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 |
|---|---|---|
| Placebo4 x 1g capsules/day | Drug | Placebo |
| MAT9001 (omega-3 pentaenoic acid)4 x 1g capsules/day | Drug | MAT9001 (omega-3-pentaenoic acid) |
Primary outcome
The percent change from baseline to end of study for MAT9001 versus Placebo
Time frame: 12 weeks
Difference between MAT9001 and placebo treatment groups in triglyceride lowering effect
1 secondary outcome
The percent change from baseline to end of study for lipids and lipid biomarkers for MAT9001 versus Placebo
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Judith Johnson study director
Matinas BioPharma
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MAT9001 (omega-3 pentaenoic acid) in people with Severe Hypertriglyceridemia, run by Matinas Biopharma, Inc.
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 10 inclusion and 27 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: withdrawn, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
The percent change from baseline to end of study for MAT9001 versus 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 16 Sep 2021.