AI Article Synopsis

  • A study was conducted to evaluate the effects and safety of GFT505, a new medication, in patients with abdominal obesity and metabolic issues like dyslipidemia and prediabetes.
  • The research involved 94 and 47 participants respectively, who received either GFT505 or a placebo for 28 to 35 days, focusing on their blood lipid and glucose levels.
  • Results showed GFT505 significantly lowered triglycerides and improved HDL cholesterol, with some positive effects on glucose metabolism indicators, suggesting its potential as a treatment for metabolic syndrome.

Article Abstract

Objective: We evaluated the metabolic effects and tolerability of GFT505, a novel dual peroxisome proliferator-activated receptor α/δ agonist, in abdominally obese patients with either combined dyslipidemia or prediabetes.

Research Design And Methods: The S1 study was conducted in 94 patients with combined dyslipidemia while the S2 study was conducted in 47 patients with prediabetes. Participants were randomly assigned in a double-blind manner to GFT505 at 80 mg/day or placebo for 28 (S1) or 35 (S2) days. Primary efficacy end points were changes from baseline at week 4 in both fasting plasma triglycerides and HDL cholesterol in the S1 group and 2-h glucose upon oral glucose tolerance test in the S2 group.

Results: In comparison with placebo, GFT505 significantly reduced fasting plasma triglycerides (S1: least squares means -16.7% [95% one-sided CI -∞ to -5.3], P = 0.005; S2: -24.8% [-∞ to -10.5], P = 0.0003) and increased HDL cholesterol (S1: 7.8% [3.0 to ∞], P = 0.004; S2: 9.3% [1.7 to ∞], P = 0.009) in both studies, whereas LDL cholesterol only decreased in S2 (-11.0% [ -∞ to -3.5], P = 0.002). In S2, GFT505 did not reduce 2-h glucose (-0.52 mmol/L [-∞ to 0.61], P = 0.18) but led to a significant decrease of homeostasis model assessment of insulin resistance (-31.4% [-∞ to 12.5], P = 0.001), fasting plasma glucose (-0.37 mmol/L [-∞ to -0.10], P = 0.01) and fructosamine (-3.6% [-∞ to -0.20], P = 0.02). GFT505 also reduced γ glutamyl transferase levels in both studies (S1: -19.9% [-∞ to -12.8], P < 0.0001; S2: -15.1% [-∞ to -1.1], P = 0.004). No specific adverse safety signals were reported during the studies.

Conclusions: GFT505 may be considered a new drug candidate for the treatment of lipid and glucose disorders associated with the metabolic syndrome.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3161281PMC
http://dx.doi.org/10.2337/dc11-0093DOI Listing

Publication Analysis

Top Keywords

patients combined
12
combined dyslipidemia
12
fasting plasma
12
α/δ agonist
8
lipid glucose
8
abdominally obese
8
obese patients
8
study conducted
8
conducted patients
8
plasma triglycerides
8

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!