Trial Outcomes & Findings for Evaluation of 3-V Bioscience-2640 to Reduce de Novo Lipogenesis in Subjects With Characteristics of Metabolic Syndrome (NCT NCT02948569)

Last Updated: 2025-05-04

Results Overview

Subject undergoes a stable isotope infusion followed by blood draws. Plasma lipid samples are measured by gas chromatography/mass spectrophotometry.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline and after 10 days of treatment

Results posted on

2025-05-04

Participant Flow

The recruitment process will include the typical flyers and notices put in public spaces. All advertisements will state the purpose of the study, eligibility criteria and will tell subjects to call into our laboratory for more information. During these calls, the study will be described briefly. A checklist will be phone through to perform initial screening for age, gender, health status. Subjects who are eligible by phone screen will be scheduled for a screening visit.

Participant milestones

Participant milestones
Measure	3-V Bioscience-2640 Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days. 3-V Bioscience-2640: Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of 3-V Bioscience-2640 to Reduce de Novo Lipogenesis in Subjects With Characteristics of Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3-V Bioscience-2640 n=12 Participants Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days. 3-V Bioscience-2640: Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days.
Age, Continuous	42.1 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 10 days of treatment

Subject undergoes a stable isotope infusion followed by blood draws. Plasma lipid samples are measured by gas chromatography/mass spectrophotometry.

Outcome measures

Outcome measures
Measure	3-V Bioscience-2640 n=12 Participants Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days. 3-V Bioscience-2640: Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days.
Change in Hepatic Lipogenesis	5.6 abs percent change fasting lipogenesis Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline and 10 days of treatment

Subject undergoes MRI of abdomen to quantify liver fat.

Outcome measures

Outcome measures
Measure	3-V Bioscience-2640 n=12 Participants Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days. 3-V Bioscience-2640: Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days.
Change in Liver Fat Measured by MRI	1.8 absolute percent change in liver fat Standard Error 1.2

SECONDARY outcome

Timeframe: Baseline and 10 days of treatment

Subjects will undergo a skin test in which 4 pieces of clear Sebutape will be placed on the forehead for 30 minutes. The tape is then removed with a sample of sebum (skin oils). The tape is shipped to a lab for processing where lipid content will be analyzed.

Outcome measures

Outcome measures
Measure	3-V Bioscience-2640 n=6 Participants Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days. 3-V Bioscience-2640: Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days.
Change in Skin Sebum Production	6.76 Absolute change sebum TG (nmol/sample)) Standard Error 2.08

Adverse Events

3-V Bioscience-2640

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	3-V Bioscience-2640 n=12 participants at risk Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days. 3-V Bioscience-2640: Subjects will take a singly daily dose of 3-V Bioscience-26400 before bedtime or 22:30, whichever comes first, for 10 days.
Skin and subcutaneous tissue disorders hair loss	16.7% 2/12 • Number of events 2 • 20 days The following adverse events were queried at screening and during the 6 study visits over 20 days. 1. Disturbed bowel habits 2. Constipation 3. Diarrhea 4. Dry mouth 5. Dry skin 6. Fatigue 7. Flatulence 8. Hair loss 9. Headache 10. Itching 11. Loss of appetite 12. Nausea and vomiting 13. Sleep disturbances 14. Tiredness

Additional Information

Dr. Elizabeth Parks

University of Missouri

Phone: 15738825864

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place