A Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride

NCT04754373 | Completed Phase 2

• 1 other identifier: 17GTHB
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Elevated Triglycerides

Outcome Measures

Primary Outcomes (1)

• The change in levels of fasting serum TG levels

  The primary outcome of this study is the change in levels of fasting serum TG levels from screening to week 12 in fasting serum TG levels between GFA-918 and placebo groups.

  12 weeks

Secondary Outcomes (26)

• The change in levels of triglycerides

  12 weeks

• The change in levels of total cholesterol

  12 weeks

• The change in levels of LDL-cholesterol

  12 weeks

• The change in levels of VLDL-cholesterol

  12 weeks

• The change in levels of HDL-cholesterol

  12 weeks

Other Outcomes (28)

• The incidence of adverse events with GFA-918.

  12 weeks

• The incidence of any abnormal vital signs: blood pressure (BP) and heart rate (HR), with GFA-918

  12 weeks

• The incidence of any abnormal ECG with GFA-918

  12 weeks

Study Arms (2)

GFA-918

EXPERIMENTAL

Participants will be instructed to take one GFA-918 capsule twice per day with their morning and evening meals for 12 weeks.

Dietary Supplement: GFA-918

Placebo

PLACEBO COMPARATOR

Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.

Other: Placebo

Interventions

GFA-918 DIETARY_SUPPLEMENT

Participants will be instructed to take one GFA-918 (125000 FIP Units of Lipase AY) capsule twice per day with their morning and evening meals for 12 weeks.

GFA-918

Placebo OTHER

Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and male within the age range of 30 to 70 at screening;
• BMI of 20 - 34.9 kg/m2 at screening;
• 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);
• Sedentary life style as defined by Sedentary Behavior Questionnaire (Appendix II) at screening;
• Serum triglycerides 1.91 - 3.93 mmol/L (175 - 350 mg/dL) (inclusive) at screening;
• Willing to maintain current levels of activity throughout the study;
• Stable with no health concerns for participating in the study as determined by laboratory results, and medical history;
• Willingness to complete all study visits and requirements associated with the study;
• Has access to a computer, tablet, or smart phone with internet connection;

You may not qualify if:

• Individuals who are pregnant, breastfeeding, or planning to become pregnant;
• LDL-C ≥ 4.1 mmol/L (160 mg/dL);
• Uncontrolled hypertension, defined as untreated systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg;
• 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
• 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;
• Verbal confirmation of current, or history of, bleeding disorders and/or medically prescribed anticoagulant/antiplatelet drugs (refer to Section 5.3);
• 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.
• 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
• Verbal confirmation of Type I and Type II Diabetes;
• Anti-inflammatory medication, corticosteroids, lipid lowering agents and diabetic medication (refer to Section 5.3) as assessed by the QI;
• Alcohol or drug abuse within the last 6 months;
• No more than 2 standard alcoholic drinks per day;
• Verbal confirmation of marijuana use \>4 times a week
• Tobacco products, including e-cigarette; dose and frequency will be assessed on a case by case basis by the QI
• Participation in a clinical research study within 30 days of enrollment;

Sponsors & Collaborators

• BIO-CAT Microbials, LLC: lead
• KGK Science Inc.: collaborator

Study Sites (2)

KGK Science

London, Ontario, N6A 5R8, Canada

Location

Canadian College of Naturopathic Medicine

Toronto, Ontario, M2K 1E2, Canada

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

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

Study Officials

• David Crowley, MD

  KGK Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: July 13, 2018
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)