Phase 2 N=12 Treatment

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

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02948569 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcome: Primary: Change in Hepatic Lipogenesis — 5.6 abs percent change fasting lipogenesis

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 3-V Bioscience-2640 (Drug)
Age: Adult · 35+ yrs
Sex: Male
Sponsor: University of Missouri-Columbia
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Hepatic Lipogenesis	5.6	—
SECONDARY Change in Liver Fat Measured by MRI	1.8	—
SECONDARY Change in Skin Sebum Production	6.76	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Men with characteristics of metabolic syndrome
Waist circumference greater than 40 in (102 cm)
Plasma TG greater than 150 mg/dL
HDL cholesterol less than 40 mg/dL
Blood pressure greater than or equal to 130/85 mmHg
Fasting plasma glucose greater than 100 mg/dL but less than 126 mg/dL
Fasting insulin great than 10 microunits/mL
35-60 years of age
Overweight/obese subjects with BMI 27.1 - 35.0 kg/m2
Family history of cardiovascular disease or diabetes
Habitual diets containing ≥ 5.0% of energy from added sugars
Creatinine clearance of ≥80 mL/min

Exclusion Criteria

Diagnosed cardiovascular disease (unstable angina, New York Heart Association angina > Grade 2), abnormal thyroid function or liver/kidney disease, renal dysfunction (defined by a glomerular filtration rate 500 mL within the past 8 wks.
Patients with uncontrolled hypertension, i.e. ≥160/95 mmHg.
Patients with known cardiac abnormalities.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02948569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.