• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Zafgen initiates phase I trial of ZGN-1061

Zafgen initiates phase I trial of ZGN-1061

September 21, 2016
CenterWatch Staff

Zafgen, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, has announced that the company has recently initiated dosing in the multiple ascending dose (MAD) cohorts of its ongoing phase I clinical trial of ZGN-1061. The initiation of the MAD portion was triggered following a review of the initial safety and tolerability data from the first two cohorts of the single ascending dose (SAD) portion of the clinical trial. ZGN-1061 is a second-generation, differentiated MetAP2 inhibitor in development for severe and complicated obesity indications.  

“For the last decade Zafgen has been studying the MetAP2 pathway to inform the development of molecules that will leverage the powerful benefits of MetAP2 inhibition, while minimizing off-target effects. Based on this work we have optimized ZGN-1061 to deliver an efficacy and safety profile appropriate for development in prevalent obesity-related disorders,” said Thomas Hughes, Ph.D., president and chief executive officer of Zafgen. “This clinical trial is an important first step as we look to validate the clinical profile of ZGN-1061. Initial results show ZGN-1061 exhibits pharmacokinetic properties in humans within our specified target range, translating to encouraging early safety and tolerability that support our plans for continued development of this promising candidate.”

The phase I clinical trial is evaluating safety, tolerability, and weight loss efficacy over four weeks of treatment. The clinical trial includes a SAD portion, which will enroll up to 48 healthy subjects across up to six cohorts of single escalating doses of ZGN-1061. The clinical trial also includes a MAD portion, which is evaluating twice-weekly ZGN-1061 over four weeks in up to 24 obese subjects. Key elements of the clinical trial involve evaluation of the uptake and elimination of ZGN-1061, or pharmacokinetics, and evaluation of endpoints related to blood coagulation. The Company continues to expect top-line data from the clinical trial by the end of the first quarter of 2017.

ZGN-1061, is a fumagillin-class MetAP2 inhibitor that originated from Zafgen's discovery program as part of a multi-year campaign to identify novel compounds that avoided limiting preclinical safety concerns observed with its first-generation MetAP2 inhibitor, beloranib, including teratogenicity and adverse effects on testicular function. The compound has metabolic efficacy, potency, and range of activity in animal models of obesity similar to beloranib, but displays highly differentiated safety properties and a reduced potential to impact thrombosis, supporting the value of the compound as a more highly optimized MetAP2 inhibitor.

“The clinical trial is progressing well, and we are particularly encouraged that there have been no significant safety signals or tolerability concerns observed in patients treated to date,” stated Dennis Kim, M.D., chief medical officer of Zafgen. “We look forward to further advancing this clinical trial, the results of which will provide us with important insights on the potential of ZGN-1061 in severe and complicated obesity, and help inform the doses, design, and patient population for our phase II program.”

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing