Clinical trial NCT04754373: A Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Elevated Triglycerides
Lead sponsor: BIO-CAT, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2021-02-15
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, a lipase -sourced from a nonpyrogenic yeast, Candida rugosa, will be investigated to establish optimal TG levels in adults in a 12-week supplementation period. The investigational product provides a lipase formulation that is stable and active in acidic and neutral pH environments, while also fully digesting TGs into free fatty acids and glycerol which is beyond the scope of pancreatic lipase (Schuler et al. 2012). This will be a novel study investigating the effects of C. rugosa lipase on adults with slightly elevated TG levels.


Eligibility criteria: Inclusion Criteria:

1. Females and male within the age range of 30 to 70 at screening;
2. BMI of 20 - 34.9 kg/m2 at screening;
3. Not of child bearing potential, which is defined as females who have had hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) OR,

   Female participants of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result, prior to enrollment. All hormonal birth controls require a minimum stability of three months and remain consistent throughout the study. Acceptable methods of birth control include:
   * Hormonal contraceptives; oral, hormone patch (Ortho Evra), vaginal ring (NuvaRing), injectable (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   * Double-barrier method
   * Intrauterine devices
   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
   * Vasectomy of partner (shown successful as per appropriate follow-up);
4. Sedentary life style as defined by Sedentary Behavior Questionnaire (Appendix II) at screening;
5. Serum triglycerides 1.91 - 3.93 mmol/L (175 - 350 mg/dL) (inclusive) at screening;
6. Willing to maintain current levels of activity throughout the study;
7. Stable with no health concerns for participating in the study as determined by laboratory results, and medical history;
8. Willingness to complete all study visits and requirements associated with the study;
9. Has access to a computer, tablet, or smart phone with internet connection;
10. Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

1. Individuals who are pregnant, breastfeeding, or planning to become pregnant;
2. LDL-C ≥ 4.1 mmol/L (160 mg/dL);
3. Uncontrolled hypertension, defined as untreated systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg;
4. Cancer(s), except skin cancers completely excised with no chemotherapy or radiation with a negative follow up. and cancer(s) in full remission for more than five years after diagnosis
5. Immunocompromised individuals such as those that have undergone organ transplantation, those with rheumatoid arthritis, or those diagnosed with human immunodeficiency virus (HIV) or AIDS by verbal confirmation;
6. Verbal confirmation of current, or history of, bleeding disorders and/or medically prescribed anticoagulant/antiplatelet drugs (refer to Section 5.3);
7. Verbal confirmation of current unstable thyroid disease state; however, participants who have been on stable medication for \>6 months will be eligible to participate but will be assessed on a case by case basis by the QI.
8. Verbal confirmation of GI disorders and on anti-inflammatory drugs to control GI disorders; however, participants who have been on stable medication for \>6 months will be eligible to participate but will be assessed on a case by case basis by the QI
9. Verbal confirmation of Type I and Type II Diabetes;
10. Anti-inflammatory medication, corticosteroids, lipid lowering agents and diabetic medication (refer to Section 5.3) as assessed by the QI;
11. Alcohol or drug abuse within the last 6 months;
12. No more than 2 standard alcoholic drinks per day;
13. Verbal confirmation of marijuana use \>4 times a week
14. Tobacco products, including e-cigarette; dose and frequency will be assessed on a case by case basis by the QI
15. Participation in a clinical research study within 30 days of enrollment;
16. Allergy or sensitivity to study product ingredients;
17. Clinically significant abnormal laboratory results at screening;
18. Unstable medical conditions as assessed by the Qualified Investigator;
19. Individuals who are cognitively impaired and/or unable to give informed consent;
20. Any other condition which in the Qualified Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant.

Primary outcomes:
measure: The change in levels of fasting serum TG levels
timeFrame: 12 weeks
Secondary outcomes:
measure: The change in levels of triglycerides
timeFrame: 12 weeks
measure: The change in levels of total cholesterol
timeFrame: 12 weeks
measure: The change in levels of LDL-cholesterol
timeFrame: 12 weeks
measure: The change in levels of VLDL-cholesterol
timeFrame: 12 weeks
measure: The change in levels of HDL-cholesterol
timeFrame: 12 weeks
measure: The change in levels of ApoA-I
timeFrame: 12 weeks
measure: The change in levels of LDL-C: HDL-C
timeFrame: 12 weeks
measure: The change in levels of TC: HDL-C
timeFrame: 12 weeks
measure: The change in levels of apolipoprotein A1 (ApoA-1)
timeFrame: 12 weeks
measure: The change in levels of CRP
timeFrame: 12 weeks
measure: The change in levels of TNF-α
timeFrame: 12 weeks
measure: The change in levels of IL-6
timeFrame: 12 weeks
measure: The change in body weight
timeFrame: 12 weeks
measure: The change in body mass index (BMI)
timeFrame: 12 weeks
measure: A clinically relevant change in TG after the 12-week supplementation with GFA-918 as assessed by a 1 mmol/L decrease in TG.
timeFrame: 12 weeks
measure: A clinically relevant change in HDL-C after supplementation with GFA-918 defined as at least 0.026 mmol/L (1 mg/dL) or 1% increase
timeFrame: 12 weeks
measure: The clinically relevant change in LDL-C after supplementation with GFA-918 defined as a minimal 1% decrease
timeFrame: 12 weeks
measure: The changes during the follow up period, week 12 to week 14, in levels of fasting serum TG levels
timeFrame: 14 weeks
measure: The changes during the follow up period, week 12 to week 14, in complete lipid profile
timeFrame: 14 weeks
measure: The changes during the follow up period, week 12 to week 14, in levels of ApoA-1
timeFrame: 14 weeks
measure: The changes during the follow up period, week 12 to week 14, in levels of inflammatory biomarkers
timeFrame: 14 weeks
measure: The changes during the follow up period, week 12 to week 14, in body weight
timeFrame: 14 weeks
measure: The changes during the follow up period, week 12 to week 14, in BMI
timeFrame: 14 weeks
measure: The clinical significant changes during the follow up period, week 12 to week 14, in levels of TG
timeFrame: 14 weeks
measure: The clinical significant changes during the follow up period, week 12 to week 14, in levels of HDL-C
timeFrame: 14 weeks
measure: The clinical significant changes during the follow up period, week 12 to week 14, in levels of LDL-C
timeFrame: 14 weeks
Other outcomes:
measure: The incidence of adverse events with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal vital signs: blood pressure (BP) and heart rate (HR), with GFA-918
timeFrame: 12 weeks
measure: The incidence of any abnormal ECG with GFA-918
timeFrame: 12 weeks
measure: The incidence of any abnormal hematology (white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal hematology; red blood cell (RBC) count, with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal hematology; hematocrit, with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal hematology; platelet count, with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal hematology; RBC indices (mean corpuscular volume (MCV)) with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal hematology; RBC indices (mean corpuscular hemoglobin (MCH)), with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal hematology; RBC indices (mean corpuscular hemoglobin concentration (MCHC)), with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal hematology; RBC indices (red cell distribution width (RDW)) with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal liver function measured: alanine aminotransferase (ALT), with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal liver function measured: aspartate aminotransferase (AST), with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal liver function measured: bilirubin, with GFA-918.
timeFrame: 12 weeks
measure: The incidence of any abnormal kidney function parameters: serum creatinine, with GFA-918
timeFrame: 12 weeks
measure: The incidence of any abnormal kidney function parameters: estimated glomerular filtration rate (eGFR), with GFA-918
timeFrame: 12 weeks
measure: The incidence of any abnormal kidney function parameters: electrolytes (Na, K, Cl), with GFA-918
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: colour
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: appearance
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: specific gravity
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: pH
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: presence of protein
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: glucose
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: ketones
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: blood
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: nitrites
timeFrame: 12 weeks
measure: The incidence of any abnormal urinalysis measurements: leucocyte esterase
timeFrame: 12 weeks
measure: The incidence of adverse events or abnormal safety outcomes during the follow up period, week 12 to week 14
timeFrame: 14 weeks
Locations:
city: London
country: Canada
facility: KGK Science
state: Ontario
city: Toronto
country: Canada
facility: Canadian College of Naturopathic Medicine
state: Ontario
Study officials:
affiliation: KGK Science
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: