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

NCT02948569 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 2006432
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome

Keywords

Obesity; Hyperlipidemia; Impaired fasting glucose; Insulin resistance; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Hepatic Lipogenesis

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

  Baseline and after 10 days of treatment

Secondary Outcomes (2)

• Change in Liver Fat Measured by MRI

  Baseline and 10 days of treatment

• Change in Skin Sebum Production

  Baseline and 10 days of treatment

Study Arms (1)

3-V Bioscience-2640

EXPERIMENTAL

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

Interventions

3-V Bioscience-2640 DRUG

Subjects will take a singly daily dose of 3-V Bioscience-26400 before bedtime or 22:30, whichever comes first, for 10 days.

3-V Bioscience-2640

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• Chronic skin disorder or treatment for acne
• History of clinically significant dry eye or eye diseases such as glaucoma
• Diabetes defined as fasting glucose ≥ 125 mg/dL or HbA1c ≥ 6.5%
• Habitual diets with low content of added sugars (\<5% of total energy)
• Any tobacco use
• 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)
• Contraindications of MRI
• Alcohol intake weekly greater than 56 g/week (4 standard drinks/wk).
• Major surgery or donation of blood of \>500 mL within the past 8 wks.
• Patients with uncontrolled hypertension, i.e. ≥160/95 mmHg.
• Patients with known cardiac abnormalities.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Sagimet Biosciences Inc.: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65201, United States

Location

Related Publications (1)

• Syed-Abdul MM, Parks EJ, Gaballah AH, Bingham K, Hammoud GM, Kemble G, Buckley D, McCulloch W, Manrique-Acevedo C. Fatty Acid Synthase Inhibitor TVB-2640 Reduces Hepatic de Novo Lipogenesis in Males With Metabolic Abnormalities. Hepatology. 2020 Jul;72(1):103-118. doi: 10.1002/hep.31000. Epub 2020 May 7.

  PMID: 31630414 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Hyperlipidemias; Insulin Resistance; Hypertension

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Elizabeth Parks
• Organization: University of Missouri

parksej@missouri.edu

15738825864

Study Officials

• Elizabeth J Parks, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: There is only one treatment arm in this study and the subjects are all aware that they are on active treatment. The outcomes assessor will be masked as to which data are from the baseline visit and which are from the follow-up visit. In other words, data will be analyzed in the lab in a blinded fashion as to whether the samples are from before or after treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Nutrition & Exercise Physiology-MED

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 28, 2016
• Study Start: February 1, 2017
• Primary Completion: December 18, 2017
• Study Completion: January 30, 2019
• Last Updated: May 4, 2025
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)