Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL

NCT04662528 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: MAT-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Severe Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• The percent change from baseline to end of study for MAT9001 versus Placebo

  Difference between MAT9001 and placebo treatment groups in triglyceride lowering effect

  12 weeks

Secondary Outcomes (1)

• The percent change from baseline to end of study for lipids and lipid biomarkers for MAT9001 versus Placebo

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

MAT9001 (omega-3-pentaenoic acid)

EXPERIMENTAL

Drug: MAT9001 (omega-3 pentaenoic acid)

Interventions

Placebo DRUG

4 x 1g capsules/day

Placebo

MAT9001 (omega-3 pentaenoic acid) DRUG

4 x 1g capsules/day

MAT9001 (omega-3-pentaenoic acid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Matinas Biopharma, Inc: lead
• Covance: collaborator

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

MAT9001

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Judith Johnson

  Matinas BioPharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: June 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share