NGM Study 15-0106

A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients with PSC
(Study 15-0106)

This research study is now enrolling

NGM282 is an investigational drug. The safety and efficacy of NGM282 in patients with primary sclerosing cholangitis have not been established. NGM282 has not been approved by the FDA or any other regulatory agency for the treatment of any disease.

The Role of Bile Acids in PSC

  • Bile acids are made in your liver and play an important role in helping to break down fat and absorb some medications and vitamins from your gut
  • However, some of these bile acids can cause injury to your liver if they accumulate like they do in PSC
  • FGF19 is a hormone that is made in your intestine that helps control how much bile acids your liver makes
  • Increasing the levels of FGF19 appear to decrease bile acids and may be a way to reduce liver injury in PSC and other liver diseases

What is NGM282?

About NGM282:

  • NGM282 is an investigational drug which is very similar to the gut hormone FGF19 that is naturally made by your body
  • It works by blocking your liver from making some of the toxic bile acids and may prevent some of the injury to the liver in PSC
  • NGM282 also has some effect on how your body handles blood sugars and cholesterol
  • NGM282 is a self-administered injection given just under the skin (subcutaneous) with a small needle

What Patients has NGM282 been Studied in to Date?

  • NGM282 has been or is currently being studied in over 250 patients including normal volunteers and patients with Type 2 Diabetes, NASH, and PBC
  • NGM is currently also enrolling a Phase 2 study in patients with PSC which you may qualify to participate

NGM282 PSC Study Design
(NGM Study 15-0106)

Phase 2, Randomized, Double-blind, Placebo-controlled study

  • Study 15-0106 is a randomized, multicenter study of 2 doses of NGM282 versus placebo
  • The study will last a total of 22 weeks, with 12 weeks of that being on study drug or placebo
  • The study design and the required study visits are in the figure below:

Main Outcome Measures:

  • The main purpose of the study is to study the impact of NGM282 on lowering alkaline phosphatase, an important marker of liver injury in PSC
  • Other things that will be studied include the side-effects of NGM282, changes in your liver disease and the impact on itching as well
  • If you have inflammatory bowel disease, the study will follow any changes in your symptoms as well

What are the Main Qualifying Criteria for this Study?

  • Male or female between 18 and 75 years of age
  • The following medical conditions are allowed:
    • Inflammatory bowel disease with no evidence of colon cancer or pre-cancer on a colonoscopy
    • Overlapping PSC and autoimmune hepatitis which is treated and stable
    • Stable cirrhosis
  • Treatment with ursodeoxycholic acid is allowed but not required
  • No evidence of bile duct cancer or other liver cancers
  • No placement or removal of a bile duct stent in the past 3 months
  • No episodes of bile duct infections (cholangitis) in the past 3 months
  • Not on a transplant list or had a liver transplant
  • Key laboratory criteria include alkaline phosphatase  > 173 IU/L and  total bilirubin < 2.5 mg/dL

There are other criteria and restrictions for this trial that should be discussed with the study investigator at the study sites.

Additional Information

For more information on this study, including study site contacts, please go to https://clinicaltrials.gov/ct2/show/NCT02704364

Clinicians may also contact NGM through Kathy Kim (kkim@ngmbio.com) or Stephen Rossi, PharmD (srossi@ngmbio.com) from NGM Biopharmaceuticals

For general information about participating in clinical trials, please go to http://www.fda.gov/ForPatients/ClinicalTrials

Trial Sites Currently Enrolling Patients

Country State City Physician Name Institution Study Coordinator
USA CA Coronado Dr. Tarek Hassanein Southern California Liver Centers Yasmeen Esshaki
USA CA Sacramento Dr. Christopher L. Bowlus UC Davis Medical Center Not Recruiting Yet
USA CO Aurora Dr. Lisa Forman Univ. of Colorado Denver Allison Pabich
USA DC Washington Dr. Coleman I. Smith Georgetown Univ. Not Recruiting Yet
USA FL Gainesville Dr. Virginia C. Clark Univ. of Florida Health Science Center Not Recruiting Yet
USA FL Miami Dr. Cynthia Levy Univ. of Miami Center for Liver Diseases Odalys Rodriguez Bravo
USA IN Indianapolis Dr. Raj Vuppalanchi Indiana Univ. Medical Grp. Regen Strief Inst. Not Recruiting Yet
USA MI Detroit Dr. Stuart Gordon Henry Ford Healthcare System Joanne Dupui
USA MO Kansas City Dr. Bradley l. Freilich Kansas City Gastroenterology & Hepatology Laurie Lynn
USA MO St. Louis Dr. Bruce Bacon Saint Louis Univ. Not Recruiting Yet
USA NC Durham Dr. Andrew Muir Duke Univ. Medical Center Tameka Street
USA NY New York Dr. Joseph A. Odin Mount Sinai School of Medicine Not Recruiting Yet
USA OH Cincinnati Dr. Stephen Zucker Univ. of Cincinnati College of Medicine Not Recruiting Yet
USA TN Nashville Dr. Andrew E. Scanga Vanderbilt Univ. Medical Center Melanie J. Dean-Brenner
USA TX Dallas Dr. James Trotter Texas Digestive Disease Center Carlos Duncker, M.D
USA TX Dallas Dr. Maryln J. Mayo Univ. of Texas Soutwest Medical Center Not Recruiting Yet
USA TX Houston Dr. John Vierling Baylor Univ. Jana L. Lee
USA VA Charlottesville Dr. Stephen Caldwell Univ. of Virginia Not Recruiting Yet
USA VA Newport News Dr. Nadege Gunn Bon Secours Health System Joyce Soublet
USA VA Norfolk Dr. Michael Ryan Digestive & Liver Disease Specialists Pamela Hoisington
USA VA Richmond Dr. Mitchell Shiffman Bon Secours Health System Susan Volllum
USA WA Seattle Dr. Charles S. Landis Univ. of Washington Lynn Gemmell
FR   Paris Dr. Oliver Chazouilleres Hôpital Saint Antoine Karima Ben Belkacem
NL   Amsterdam Dr. Ulrich Beuers Academisch Medisch Centrum Amsterdam Martine Peters
NL   Amsterdam Dr. Karin van Nieuwkerk VU Medisch Centrum Lida Beneken Kolmer
NL   Leiden Dr. Bart van Hoek Leids Universitair Medisch Centrum Not Recruiting Yet
NL   Nijmegen Dr. Joost Drenth Radboud Univ. Nijmegen Medical Centre Sonja Cuppen
NL   Rotterdam Dr. Henk van Buuren Erasmus MC Not Recruiting Yet
NL   Utrecht Dr. Karel van Erpecum Universitair Medisch Centrum Utrecht Not Recruiting Yet
UK   Birmingham Dr. Gideon Hirschfield New Queen Elizabeth Hosp. Not Recruiting Yet
UK   Liverpool Dr. Imran Patanwala Royal Liverpool & Broadgreen Univ. Hosp. Kate Martin
UK   London Dr. Douglas Throburn Royal Free Hosp. Not Recruiting Yet
UK   Newcastle Dr. Mark Hudson Freeman Hosp. Not Recruiting Yet
UK   Norwich Dr. Simon Rushbrook Norfolk & Norwich Univ. Hosp. David Tomlinson

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NGM Biopharmaceuticals, Inc.
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South San Francisco, CA 94080-7014
650.243.5555

Disclaimer: The information in this website is not intended to promote NGM282 or any product and make no representations and warranties. Also potential subjects should not make any healthcare decisions based on the information presented.