Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Initiation of FLINT Announced by NIDDK: Study of Intercept Pharmaceuticals’ Obeticholic Acid (INT-747) in NASH

March 29, 2011 By Bio-Medicine.Org

NEW YORK, March 29, 2011 /PRNewswire/ — Intercept
Pharmaceuticals, Inc., has been informed by the National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK) of the
National Institutes of Health that patient enrollment has started
in a new clinical trial in patients with nonalcoholic
steatohepatitis (NASH), which will evaluate Intercept’s
first-in-class farnesoid X receptor (FXR) agonist obeticholic acid
(OCA) as a novel therapy for NASH. The FXR Ligand NASH Treatment
(FLINT) trial is a double blind, placebo controlled, multi-center
clinical study that will evaluate the effects of OCA compared with
placebo in adult NASH patients.

NASH is a more serious form of nonalcoholic fatty liver disease
(NAFLD) and occurs in patients who drink little or no alcohol. The
disease is believed to be caused by abnormal metabolism of fats
and, although it is often associated with obesity and insulin
resistance, it also occurs in lean individuals. NASH is associated
with fibrosis (scarring) in the liver that may lead to cirrhosis,
liver cancer and death, and the disease also carries an additional
mortality risk due to heart disease. NASH is now the most common
liver disease in the developed world, affecting at least 3-5% of
the U.S. population and up to 50% of patients with morbid obesity.
 There is currently no approved treatment for the disease.

FLINT will enroll 280 patients at the eight U.S. centers
comprising the NIDDK-sponsored NASH Clinical Research Network.
 The primary endpoint in the 72 week study will be determined
by liver biopsy and is defined as an improvement in the NAFLD
activity score with no worsening of liver fibrosis.  NIDDK is
providing the majority of funding for the study and is partnering
with Intercept under a cooperative research and development
agreement (CRADA).

“It is a privilege to be collaborating with this group of
leading NASH investigators and the NIDDK,” commented David Shapiro,
MD, Chief Medical O

‘/>”/>

SOURCE

Related Articles Read More >

Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I
Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech