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

• Status: Completed
• Trial end date: 2017-12-18
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Collaborators: 3V Biosciences, Inc.; Sagimet Biosciences Inc.

Criteria

Inclusion Criteria:

1. Men with characteristics of metabolic syndrome

1. Waist circumference greater than 40 in (102 cm)

2. Plasma TG greater than 150 mg/dL

3. HDL cholesterol less than 40 mg/dL

4. Blood pressure greater than or equal to 130/85 mmHg

5. Fasting plasma glucose greater than 100 mg/dL but less than 126 mg/dL

6. Fasting insulin great than 10 microunits/mL

2. 35-60 years of age

3. Overweight/obese subjects with BMI 27.1 - 35.0 kg/m2

4. Family history of cardiovascular disease or diabetes

5. Habitual diets containing ≥ 5.0% of energy from added sugars

6. Creatinine clearance of ≥80 mL/min

Exclusion Criteria:

1. 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 <80 mL/min)

2. Chronic skin disorder or treatment for acne

3. History of clinically significant dry eye or eye diseases such as glaucoma

4. Diabetes defined as fasting glucose ≥ 125 mg/dL or HbA1c ≥ 6.5%

5. Habitual diets with low content of added sugars (<5% of total energy)

6. Any tobacco use

7. Elevated liver enzymes ≥ 3x normal (regional norms Alanine transaminase <42 U/L, aspartate aminotransferase <40 U/L, and gamma-glutamyl transferase 8-61 U/L)

8. Contraindications of MRI

9. Alcohol intake weekly greater than 56 g/week (4 standard drinks/wk).

10. Major surgery or donation of blood of >500 mL within the past 8 wks.

11. Patients with uncontrolled hypertension, i.e. ≥160/95 mmHg.

12. Patients with known cardiac abnormalities.