Drug intelligence / Profile preview

metformin + fenofibrate placebo

Development stage
Unknown
Lead developer
University of Pennsylvania
Modality
Small Molecules
Administration
Oral
01

Overview

Metformin + fenofibrate placebo refers to the pharmacologically inactive control intervention utilized in the Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) study (NCT00650754). This phase 2 clinical trial, sponsored by the University of Pennsylvania, was designed to evaluate the individual and combined therapeutic effects of metformin (an insulin sensitizer) and fenofibrate (a PPAR-alpha agonist) in adults presenting with metabolic syndrome, insulin resistance, and atherogenic dyslipidemia (specifically elevated triglycerides). The placebo arm was administered matching non-active formulations that mimicked the appearance and dosing schedule of the active treatments (2000 mg/day of metformin and 145 mg/day of fenofibrate) to maintain the double-blind nature of the study. As a placebo, it contains no active pharmaceutical ingredients and serves as a comparative baseline to differentiate the pharmacological effects of the active drugs from the placebo effect and natural disease progression.

Other names
Metformin and Fenofibrate placebo
02

Targets

AMPK (Adenosine monophosphate–activated protein kinase)PPARA (Peroxisome proliferator-activated receptor alpha)

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