Elevated TriglyceridesPhase 2NCT04754373
A Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride
A Phase 2 study testing GFA-918 in people with Elevated Triglycerides, run by BIO-CAT Microbials, LLC at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Triglycerides
- What is being tested?
- GFA-918
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Jul 2018to 6 Dec 2021
- Phase
- Phase 2
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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;
- Has given voluntary, written, informed consent to participate in the study.
Who cannot join
- 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);
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- 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;
- Allergy or sensitivity to study product ingredients;
- Clinically significant abnormal laboratory results at screening;
- Unstable medical conditions as assessed by the Qualified Investigator;
- Individuals who are cognitively impaired and/or unable to give informed consent;
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
KGK Science
London, Ontario, N6A 5R8
Canadian College of Naturopathic Medicine
Toronto, Ontario, M2K 1E2
About this study
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
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
- Being tested
- GFA-918, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFA-918Dietary 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.
PlaceboOther
Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (26)
The change in levels of triglycerides
The change from baseline to week 12 in lipid profile (levels of triglycerides) between GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of total cholesterol
The change from baseline to week 12 in lipid profile (levels of total cholesterol) between GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of LDL-cholesterol
The change from baseline to week 12 in lipid profile ( levels of LDL-cholesterol) between GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of VLDL-cholesterol
The change from baseline to week 12 in lipid profile (levels of VLDL-cholesterol) between GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of HDL-cholesterol
The change from baseline to week 12 in lipid profile (levels of HDL-cholesterol) between GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of ApoA-I
The change from baseline to week 12 in lipid profile (levels of ApoA-I) between GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of LDL-C: HDL-C
The change from baseline to week 12 in lipid profile (LDL-C: HDL-C) between GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of TC: HDL-C
The change from baseline to week 12 in lipid profile (TC: HDL-C) between GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of apolipoprotein A1 (ApoA-1)
The change from baseline to week 12 in apolipoprotein A1 (levels of ApoA-1) between GFA-918 and placebo groups.
Measured: 12 weeks
The change in levels of CRP
The change from baseline to week 12 in levels of the inflammatory biomarker, CRP, between the GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of TNF-α
The change from baseline to week 12 in levels of the inflammatory biomarker, TNF-α, between the GFA-918 and placebo groups
Measured: 12 weeks
The change in levels of IL-6
The change from baseline to week 12 in levels of the inflammatory biomarker, IL-6, between the GFA-918 and placebo groups
Measured: 12 weeks
The change in body weight
The change from screening to week 12 in body weight between GFA-918 and placebo groups.
Measured: 12 weeks
The change in body mass index (BMI)
The change from screening to week 12 in body mass index (BMI) between the GFA-918 and placebo groups
Measured: 12 weeks
A clinically relevant change in TG after the 12-week supplementation with GFA-918 as assessed by a 1 mmol/L decrease in TG.
6A clinically relevant change in TG from screening to week 12 after the 12-week supplementation with GFA-918 as assessed by a 1 mmol/L decrease in TG.
Measured: 12 weeks
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
A clinically relevant change in HDL-C, from baseline to week 12 after supplementation with GFA-918 defined as at least 0.026 mmol/L (1 mg/dL) or 1% increase
Measured: 12 weeks
The clinically relevant change in LDL-C after supplementation with GFA-918 defined as a minimal 1% decrease
The clinically relevant change in LDL-C, from baseline to week 12 after supplementation with GFA-918 defined as a minimal 1% decrease
Measured: 12 weeks
The changes during the follow up period, week 12 to week 14, in levels of fasting serum TG levels
The changes during the follow up period, week 12 to week 14, in fasting serum TG levels between GFA-918 and placebo groups.
Measured: 14 weeks
The changes during the follow up period, week 12 to week 14, in complete lipid profile
The changes during the follow up period, week 12 to week 14, complete lipid profile between GFA-918 and placebo groups.
Measured: 14 weeks
The changes during the follow up period, week 12 to week 14, in levels of ApoA-1
The changes during the follow up period, week 12 to week 14, ApoA-1, between GFA-918 and placebo groups.
Measured: 14 weeks
The changes during the follow up period, week 12 to week 14, in levels of inflammatory biomarkers
The changes during the follow up period, week 12 to week 14, inflammatory biomarkers, between GFA-918 and placebo groups.
Measured: 14 weeks
The changes during the follow up period, week 12 to week 14, in body weight
The changes during the follow up period, week 12 to week 14, body weight between GFA-918 and placebo groups.
Measured: 14 weeks
The changes during the follow up period, week 12 to week 14, in BMI
The changes during the follow up period, week 12 to week 14, BMI, between GFA-918 and placebo groups.
Measured: 14 weeks
The clinical significant changes during the follow up period, week 12 to week 14, in levels of TG
The clinical significant changes during the follow up period, week 12 to week 14, in TG, between GFA-918 and placebo groups.
Measured: 14 weeks
The clinical significant changes during the follow up period, week 12 to week 14, in levels of HDL-C
The clinical significant changes during the follow up period, week 12 to week 14, in HDL-C, between GFA-918 and placebo groups.
Measured: 14 weeks
The clinical significant changes during the follow up period, week 12 to week 14, in levels of LDL-C
The clinical significant changes during the follow up period, week 12 to week 14, in LDL-C, between GFA-918 and placebo groups.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start13 Jul 2018
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated TriglyceridesStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- BIO-CAT Microbials, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754373
- Sponsor's protocol ID
- 17GTHB
- Status last verified
- Oct 2021
- First submitted
- 10 Feb 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04754373
- Acronym / sponsor ID
- 17GTHB
- Conditions
- Elevated Triglycerides
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BIO-CAT Microbials, LLCIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 15 Feb 2021 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GFA-918 | Experimental | Dietary Supplement: GFA-918Participants will be instructed to take one GFA-918 capsule twice per day with their morning and evening meals for 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Sedentary life style as defined by Sedentary Behavior Questionnaire (Appendix II) at screening;
Key exclusion criteria (20 listed)
- 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;
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 |
|---|---|---|
| GFA-918Participants 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. | Dietary supplement | GFA-918 |
| PlaceboParticipants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks. | Other | Placebo |
Primary outcome
The change in levels of fasting serum TG levels
Time frame: 12 weeks
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.
26 secondary outcomes
The change in levels of triglycerides
Time frame: 12 weeks
The change in levels of total cholesterol
Time frame: 12 weeks
The change in levels of LDL-cholesterol
Time frame: 12 weeks
The change in levels of VLDL-cholesterol
Time frame: 12 weeks
The change in levels of HDL-cholesterol
Time frame: 12 weeks
The change in levels of ApoA-I
Time frame: 12 weeks
The change in levels of LDL-C: HDL-C
Time frame: 12 weeks
The change in levels of TC: HDL-C
Time frame: 12 weeks
The change in levels of apolipoprotein A1 (ApoA-1)
Time frame: 12 weeks
The change in levels of CRP
Time frame: 12 weeks
The change in levels of TNF-α
Time frame: 12 weeks
The change in levels of IL-6
Time frame: 12 weeks
The change in body weight
Time frame: 12 weeks
The change in body mass index (BMI)
Time frame: 12 weeks
A clinically relevant change in TG after the 12-week supplementation with GFA-918 as assessed by a 1 mmol/L decrease in TG.
Time frame: 12 weeks
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
Time frame: 12 weeks
The clinically relevant change in LDL-C after supplementation with GFA-918 defined as a minimal 1% decrease
Time frame: 12 weeks
The changes during the follow up period, week 12 to week 14, in levels of fasting serum TG levels
Time frame: 14 weeks
The changes during the follow up period, week 12 to week 14, in complete lipid profile
Time frame: 14 weeks
The changes during the follow up period, week 12 to week 14, in levels of ApoA-1
Time frame: 14 weeks
The changes during the follow up period, week 12 to week 14, in levels of inflammatory biomarkers
Time frame: 14 weeks
The changes during the follow up period, week 12 to week 14, in body weight
Time frame: 14 weeks
The changes during the follow up period, week 12 to week 14, in BMI
Time frame: 14 weeks
The clinical significant changes during the follow up period, week 12 to week 14, in levels of TG
Time frame: 14 weeks
The clinical significant changes during the follow up period, week 12 to week 14, in levels of HDL-C
Time frame: 14 weeks
The clinical significant changes during the follow up period, week 12 to week 14, in levels of LDL-C
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 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.
David Crowley, MD principal investigator
KGK Science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GFA-918 in people with Elevated Triglycerides, run by BIO-CAT Microbials, LLC at 2 sites in Canada.
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 16 inclusion and 20 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: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change in levels of fasting serum TG levels (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 22 Dec 2021.