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A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1) (TRILOGY 1)

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ClinicalTrials.gov Identifier: NCT03398005
Recruitment Status : Active, not recruiting
First Posted : January 12, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Acasti Pharma Inc.

Brief Summary:

The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting triglyceride (TG) levels in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment.

Approximately 615 subjects will be screened to obtain 245 randomized subjects following a 2.5:1 treatment allocation ratio (CaPre: placebo).


Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: CaPre Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-center, Placebo-controlled, Randomized, Double-blind 26-week Study to Assess the Safety and Efficacy of CaPre® in Patients With Severe Hypertriglyceridemia.
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Experimental: CaPre Drug: CaPre
4 x 1 g capsules administered orally once a day for 26 weeks

Placebo Comparator: Placebo Drug: Placebo
4 x 1 g capsules administered orally once a day for 26 weeks




Primary Outcome Measures :
  1. Percent change in fasting TG levels from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L). [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in non-HDL-C. [ Time Frame: Week 12 ]
  2. Percent change from baseline (Week -1 and 0) to Week 12 (average of Week 11 and 12) in VLDL-C (β-quantification). [ Time Frame: Week 12 ]
  3. Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in HDL-C. [ Time Frame: Week 12 ]
  4. Percent change from baseline (average of Week -1 and 0) to Week 12 (average of Week 11 and 12) in LDL-C (β-quantification). [ Time Frame: Week 12 ]

Other Outcome Measures:
  1. Percent change from baseline (average of Week -2, -1, and 0) to all measured visits other than Week 12 (Week 4, Week 18 and Week 26) in TG (persistence of the effect of CaPre on TG). [ Time Frame: Week 4; Week 18; Week 24 ]
  2. Proportion of subjects with a fasting TG level below 500 mg/dL (<5.7 mmol/L) at Week 12 and at Week 26. [ Time Frame: Week 12; Week 26 ]
  3. Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and Week 12) and Week 26 in TC. [ Time Frame: Week 12; Week 26 ]
  4. Percent change from baseline (average of Week -1 and 0) to Week 12 (average of Week 11 and 12) and to Week 26 in RLP-C. [ Time Frame: Week 12; Week 26 ]
  5. Percent change from baseline (average of Week -1 and 0) to Week 26 in LDL-C (β-quantification) and VLDL-C (β-quantification). [ Time Frame: Week 26 ]
  6. Percent change from baseline (average of Week -2, -1, and 0) to Week 26 in non-HDL-C and HDL-C. [ Time Frame: Week 26 ]
  7. Percent change from baseline (Week 0) to Week 12 and to Week 26 in apo B, apo A1, apo B/apo A1 ratio, apo CIII and apo A5. [ Time Frame: Week 12; Week 26 ]
  8. Percent change from baseline (Week 0) to Week 12 and to Week 26 in lipoprotein particles concentration and size (LDL, non-HDL, HDL, IDL and VLDL). [ Time Frame: Week 12; Week 26 ]
  9. Percent change from baseline (Week 0) to Week 12 and to Week 26 in oxidized LDL. [ Time Frame: Week 12; Week 26 ]
  10. Percent change from baseline (Week 0) to Week 12 and to Week 26 in fasting serum glucose, insulin and HbA1c. [ Time Frame: Week 12; Week 26 ]
  11. Percent change from baseline (Week 0) to Week 12 and to Week 26 in HOMA-IR and HOMA-β. [ Time Frame: Week 12; Week 26 ]
  12. Percent change from baseline (Week 0) to Week 12 and to Week 26 in hs-CRP and Lp-PLA2. [ Time Frame: Week 12; Week 26 ]
  13. Change from baseline (Week 0) to Week 4, Week 12, Week 18 and to Week 26 in Total plasma EPA concentration and Total plasma DHA concentration. [ Time Frame: Week 4; Week 12; Week 18; Week 26 ]
  14. Percent change from baseline (Week 0) to Week 4, Week 12, Week 18 and to Week 26 in Total plasma EPA concentration and Total plasma DHA concentration. [ Time Frame: Week 4; Week 12; Week 18; Week 26 ]
  15. Change from baseline (Week 0) to Week 12 and to Week 26 in OM3 Index. [ Time Frame: Week 12; Week 26 ]
  16. Percent change from baseline (Week 0) to Week 12 and to Week 26 in OM3 Index. [ Time Frame: Week 12; Week 26 ]
  17. Change from baseline (Week 0) to Week 12 and to Week 26 in AA. [ Time Frame: Week 12; Week 26 ]
  18. Percent change from baseline (Week 0) to Week 12 and to Week 26 in AA. [ Time Frame: Week 12; Week 26 ]
  19. Change from baseline (Week 0) to Week 12 and to Week 26 in omega-6/omega-3 ratio. [ Time Frame: Week 12; Week 26 ]
  20. Percent change from baseline (Week 0) to Week 12 and to Week 26 in omega-6/omega-3 ratio. [ Time Frame: Week 12; Week 26 ]
  21. Change from baseline (Week 0) to Week 12 and to Week 26 in EPA/AA ratio. [ Time Frame: Week 12; Week 26 ]
  22. Percent change from baseline (Week 0) to Week 12 and to Week 26 in EPA/AA ratio. [ Time Frame: Week 12; Week 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects ≥18 years of age.
  2. Isolated hypertriglyceridemia, with triglycerides ≥500 mg/dL and <1500 mg/dL (≥5.7 mmol/L and <17.0 mmol/L) OR Mixed hyperlipidemia, with serum triglycerides ≥500 and <1500 mg/dL treated with a statin, CAI or PCSK9I inhibitor, alone or in combination, that has been stable for 6 weeks prior to randomization. If the subject is not being treated and not contraindicated, a statin and/or CAI treatment may be initiated at the discretion of the Investigator at time of screening.
  3. Willingness to maintain current physical activity level and follow the NCEP-TLC diet throughout the study.
  4. Be informed of the nature of the study and give written consent prior to any study procedure.

Exclusion Criteria:

  1. Allergy or intolerance to OM3 fatty acids, OM3-acid ethyl esters, OM3 phospholipids, fish, shell fish, or any component of the study medication.
  2. Known lipoprotein lipase impairment or deficiency, or apo CII deficiency.
  3. Subjects with lysosomal acid lipase deficiency.
  4. Body mass index greater than 45 kg/m2.
  5. Subjects who are pregnant, lactating, and subjects of childbearing potential who are either planning to become pregnant or who are not using acceptable birth control methods during study participation. Subjects of childbearing potential are subjects who have experienced menarche and do not otherwise meet the criteria for subjects not of childbearing potential, defined as:

    • Subjects who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation); or
    • Subjects who are postmenopausal, i.e., who have had a cessation of menses for at least 12 months without an alternative medical cause. A follicle stimulating hormone (FSH) test ≥40 mIU/mL may be used to confirm the post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.

    Subjects of childbearing potential must test negative for pregnancy at the time of enrollment and agree to use an acceptable contraceptive method or remain abstinent during the study or for at least 8 weeks following the last dose of study medication, whichever is longer.

  6. Subjects taking tamoxifen, estrogens, or progestins, or other medications or nutritional supplements with mechanisms modifying estrogen or progestogen pathways, who have had dosage changes within 4 weeks prior to Visit 1.
  7. Use of oral or injected corticosteroids or anabolic steroids within 6 weeks prior to randomization.
  8. History of pancreatitis within the last 6 months prior to Visit 1.
  9. History of symptomatic gallstone disease within the last 5 years, unless treated with cholecystectomy.
  10. Diabetics requiring changes in medical therapy (other than short acting insulin dosage adjustments) within 6 weeks prior to Visit 1 or who have HbA1c greater than 9.5% at Visit 1.
  11. Clinical or biochemical evidence of hyperthyroidism not stable with medication for at least 6 weeks prior to Visit 1.
  12. Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH) level more than 1.5 × upper limit of normal (ULN).
  13. Thyroid hormone replacement therapy that has not been stable for more than 6 weeks prior to Visit 1.
  14. History of cancer (other than basal cell carcinoma) within 2 years prior to Visit 1.
  15. Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, exacerbation of congestive heart failure requiring hospitalization or a change in treatment), life threatening arrhythmia, or revascularization procedure within 6 months prior to Visit 1.
  16. Use of other prohibited drugs: weight loss prescription medications; human immunodeficiency virus (HIV) protease inhibitors; cyclophosphamide; isotretinoin; routine or anticipated use of systemic corticosteroids (local, topical, inhalation, or nasal corticosteroids are permitted); or anabolic steroids.
  17. Use of any lipid-altering drug therapy, other than statins, CAI (such as ezetimibe) or PCSK9I inhibitors, alone or in combination, including niacin at a dose greater than 200 mg/day, fibrates, bile acid sequestrants, OM3 drugs (e.g., Lovaza or its generics,Vascepa, Epanova, Omtryg), OM3 supplements (e.g., fish oil, krill oil products), or any other herbal products or dietary supplements with potential lipid-altering effects. These products must be discontinued at least 6 weeks prior to randomization.
  18. Resection of an aortic aneurysm or endovascular aortic repair within 6 months prior to Visit 1.
  19. Recent history (within 6 months prior to Visit 1) or current significant nephrotic syndrome or ≥3 gram proteinuria daily, pulmonary, gastrointestinal, or immunologic disease.
  20. Poorly controlled hypertension (systolic blood pressure ≥170 mmHg and/or diastolic blood pressure ≥100 mmHg). Subjects with hypertension adequately controlled with medication are eligible provided that their antihypertensive therapy has been stable for at least 4 weeks prior to Visit 1.
  21. Recent history (past 12 months) of drug abuse or alcohol abuse, or alcohol use greater than 2 units per day (a unit of alcohol is defined as a 12-ounce (350 mL) beer, 5 ounce (150 mL) wine, or 1.5-ounce (45 mL) of 80-proof alcohol for drinks).
  22. Hepatobiliary disease or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5× ULN; if ALT/AST is >3× ULN, the levels must have been stable for 3 months prior to Visit 1.
  23. Severe renal disease as defined by less than 30 mL/min serum creatinine clearance calculated using the Cockcroft-Gault formula.
  24. Significant coagulopathy as defined by a known hereditary deficiency of coagulation factors or platelet function or an unexplained elevation of the prothrombin time (PT) international normalized ratio (INR) of ≥1.5. Subjects using warfarin [Coumadin®] or heparin are allowed. Subjects receiving other anticoagulants dabigatran, rivaroxaban, or apixaban are allowed. Subjects receiving acetylsalicylic acid (ASA) alone or in combination with other anti platelet agents (e.g., clopidogrel, prasugrel, ticagrelor) are also allowed.
  25. Unexplained creatine kinase concentration 3 × ULN.
  26. Creatine kinase elevation owing to known hereditary or acquired muscle disease.
  27. Exposure to any investigational product, within 4 weeks prior to Visit 1.
  28. Presence of any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
  29. Any life-threatening disease expected to result in death within 2 years, require frequent hospitalizations, extensive surgery or changes in medications or diet.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398005


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Locations
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United States, Alabama
Research site
Birmingham, Alabama, United States, 35242
United States, Arizona
Research site
Tucson, Arizona, United States, 85712
United States, Arkansas
Research site
Conway, Arkansas, United States, 72034
United States, California
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El Cajon, California, United States, 92020
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Fresno, California, United States, 93702
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Garden Grove, California, United States, 92844
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Lomita, California, United States, 90717
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Newport Beach, California, United States, 92663
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Tustin, California, United States, 92780
United States, Florida
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Boca Raton, Florida, United States, 33487
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Clearwater, Florida, United States, 33765
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Fort Myers, Florida, United States, 33912
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Hialeah, Florida, United States, 33012
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Homestead, Florida, United States, 33030
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Jacksonville, Florida, United States, 32256
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Kendall, Florida, United States, 33175
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Lake Worth, Florida, United States, 33461
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Miami Springs, Florida, United States, 33166
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Miami, Florida, United States, 33125
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33135
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33155
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Miami, Florida, United States, 33165
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Miami, Florida, United States, 33173
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North Miami Beach, Florida, United States, 33162
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Orlando, Florida, United States, 32825
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Pembroke Pines, Florida, United States, 33026
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Tamarac, Florida, United States, 33321
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Tampa, Florida, United States, 33603
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Wellington, Florida, United States, 33449
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West Palm Beach, Florida, United States, 33401
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West Palm Beach, Florida, United States, 33409
United States, Georgia
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Atlanta, Georgia, United States, 30345
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Gainesville, Georgia, United States, 30501
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Savannah, Georgia, United States, 31406
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Snellville, Georgia, United States, 30078
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Sugar Hill, Georgia, United States, 30518
United States, Idaho
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Meridian, Idaho, United States, 83642
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Meridian, Idaho, United States, 83646
United States, Illinois
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Gurnee, Illinois, United States, 60031
United States, Indiana
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Anderson, Indiana, United States, 46011
United States, Kentucky
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Louisville, Kentucky, United States, 40213
United States, Louisiana
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Eunice, Louisiana, United States, 70535
United States, Michigan
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Cadillac, Michigan, United States, 49601
United States, Mississippi
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Jackson, Mississippi, United States, 39202
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Olive Branch, Mississippi, United States, 38654
United States, Missouri
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Saint Louis, Missouri, United States, 63117
United States, Nebraska
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Omaha, Nebraska, United States, 68114
United States, North Carolina
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Greensboro, North Carolina, United States, 27408
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Mooresville, North Carolina, United States, 28117
United States, Ohio
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Canton, Ohio, United States, 44710
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Marion, Ohio, United States, 43302
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Maumee, Ohio, United States, 43537
United States, Oklahoma
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Norman, Oklahoma, United States, 73069
United States, Pennsylvania
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Beaver, Pennsylvania, United States, 15009
United States, South Carolina
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Spartanburg, South Carolina, United States, 29301
United States, Tennessee
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Chattanooga, Tennessee, United States, 37421
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Memphis, Tennessee, United States, 38119
United States, Texas
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Arlington, Texas, United States, 76012
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Houston, Texas, United States, 77084
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Houston, Texas, United States, 77089
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Lampasas, Texas, United States, 76550
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San Antonio, Texas, United States, 78258
United States, Utah
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Salt Lake City, Utah, United States, 84107
Research site
West Jordan, Utah, United States, 84088
United States, Virginia
Research site
Danville, Virginia, United States, 24541
United States, Washington
Research site
Bellevue, Washington, United States, 98007
United States, Wisconsin
Research site
Kenosha, Wisconsin, United States, 53144
Sponsors and Collaborators
Acasti Pharma Inc.
Investigators
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Principal Investigator: Dariush Mozaffarian, MD, DrPH Tufts Friedman School of Nutrition Science and Policy

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Responsible Party: Acasti Pharma Inc.
ClinicalTrials.gov Identifier: NCT03398005     History of Changes
Other Study ID Numbers: ACA-CAP-001
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acasti Pharma Inc.:
Omega-3 Fatty acids
Triglycerides
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases