A Phase 1/2 interventional study of 3-V Bioscience-2640 in Metabolic Syndrome, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to male participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by University of Missouri-Columbia · Phase 1/2, Interventional, and Treatment
Metabolic syndrome increases the risk for development of heart disease. Another condition associated with metabolic syndrome is fatty liver disease which is also referred to as nonalcoholic fatty liver disease (NAFLD). Recently, drugs that block fatty acid synthesis have been developed to treat cancer. These drugs are now being considered for the treatment of NAFLD. A research test designed to measure liver fatty acid synthesis involves consumption of a sugary solution and measurement of blood fats over a six-hour period. The present study will test the drug 3-V Bioscience-2640 in healthy subjects with characteristics of the metabolic syndrome before and after 10 days of treatment to determine if 50 mg/d significantly reduces liver fat synthesis and lowers liver fat storage.
The drug 3-V Bioscience-2640 has been tested previously in subjects with cancer because the lipogenesis pathway is important to the control of some cancer progression. Palmitate (C16:0), a saturated, 16-carbon fatty acid is a biomarker of lipogenesis present in blood triglyceride (TG), was found to be reduced significantly. A second biomarker of lipogenesis, malonyl carnitine, was significantly increased in patients as expected. The present study will test a lower dose (50 mg/d) than the maximum dose previously administered. Here, the subjects will be men with characteristics of the metabolic syndrome, who are otherwise healthy. The focus on subjects with metabolic syndrome is based on the fact that the future use of the drug will be in patients with NAFLD who will likely have metabolic syndrome characteristics.
In humans, the primary organ that synthesizes fatty acids is the liver, and this process occurs when simple sugars are consumed in the diet. The carbons in the sugars clear to the liver and become the molecule acetyl-Coenzyme A, which is the building block of fatty acids. The Laboratory of Elizabeth Parks, co-investigator, has developed an oral sugars tolerance test (OSTT) to determine the magnitude of liver stimulation of fatty acid synthesis when an individual consumes an oral bolus of sugars. This test involves the subject undergoing IV infusion with the stable (non-radioactive) isotope (13C1-acetate). The isotope gets incorporated into fatty acids that are being synthesized during the course of the infusion and when sugars stimulate lipogenesis, the label is more abundance. Those labeled fatty acids are detected as present in the blood very low-density lipoprotein (VLDL) component.
In the present study, the investigators will use this protocol to determine whether 10 days of drug treatment (one dose per day) will significantly reduce fasting and fructose-stimulated lipogenesis. The study is divided into 3 parts which will support the plan for minor adjustments in the dose of drug after the results from the first two research subjects are available in order to optimize the suppression of lipogenesis, while also minimizing any side effects the drug might have. The study is a repeated-measures design, with each subject serving as his own control. The study will be unblinded with respect to the research staff working directly with the subjects. However, laboratory personnel who will be running the biochemical analyses will be blinded as to whether they are analyzing baseline or post-treatment samples.
1,964 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 1,459 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men with characteristics of metabolic syndrome
Exclusion Criteria:
Subjects will take a singly daily dose of 3-V Bioscience-2640 before bedtime or 22:30, whichever comes first, for 10 days.
Drug: 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.
Change in Hepatic Lipogenesis
Subject undergoes a stable isotope infusion followed by blood draws. Plasma lipid samples are measured by gas chromatography/mass spectrophotometry.
Time frame: Baseline and after 10 days of treatment
Change in Liver Fat Measured by MRI
Subject undergoes MRI of abdomen to quantify liver fat.
Time frame: Baseline and 10 days of treatment
Change in Skin Sebum Production
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.
Time frame: Baseline and 10 days of treatment
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.
| Milestone | 3-V Bioscience-2640 |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
Subject undergoes a stable isotope infusion followed by blood draws. Plasma lipid samples are measured by gas chromatography/mass spectrophotometry.
| abs percent change fasting lipogenesis | 3-V Bioscience-2640 |
|---|---|
| Change in Hepatic Lipogenesis | 5.6 ± 1.5 |
Subject undergoes MRI of abdomen to quantify liver fat.
| absolute percent change in liver fat | 3-V Bioscience-2640 |
|---|---|
| Change in Liver Fat Measured by MRI | 1.8 ± 1.2 |
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.
| Absolute change sebum TG (nmol/sample)) | 3-V Bioscience-2640 |
|---|---|
| Change in Skin Sebum Production | 6.76 ± 2.08 |
Collected over 20 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3-V Bioscience-2640 | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Event | 3-V Bioscience-2640 |
|---|---|
| hair lossSkin and subcutaneous tissue disorders | 2/12 |
| Age, Continuous(years) | 3-V Bioscience-2640 |
|---|---|
| Mean | 42.1 ± 6.6 |
| Sex: Female, Male(Participants) | 3-V Bioscience-2640 |
|---|---|
| Female | 0 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | 3-V Bioscience-2640 |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | 3-V Bioscience-2640 |
|---|---|
| United States | 12 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Missouri-Columbia