Learn how you can get involved to support a research study for adults with nonalcoholic steatohepatitis (NASH).
About the Research Study
GlaxoSmithKline is currently conducting a phase 2b research study called HORIZON, which is enrolling participants with NASH and advanced fibrosis. The study is researching the efficacy and safety of an investigational medication, GSK4532990, and will measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo participants.
The study duration for each patient will be up to 76 weeks including the screening period. The treatment duration will be 52 weeks with a study visit every month. The study will include 3 treatment arms: 2 arms will receive the investigational drug with 2 different dosing regimens and 1 arm will receive placebo. The investigational drug will be administered via subcutaneous injection.
Participants must be 18 to 75 years of age, with a BMI of ≥ 25 kg/m2 (BMI ≥ 23 kg/m2 for Asian participants), have features of metabolic syndrome, and willing/able to get a liver scan (MRI-PDFF) and a liver biopsy at screening (if no historical liver biopsy within 6 months of screening) and at the end of the study (week 52).
How You Can Get Involved
The study is enrolling patients currently diagnosed with NASH or at risk of NASH. At-risk participants are those with hypertension, diabetes, dyslipidemia, metabolic syndrome, fatty liver on ultrasound, obesity, and AST > 20 U/L.
As a health care provider (HCP) who manages these patients, you are invited to participate in the Effectus Patient Identification and Consultation Program to help identify candidates for the HORIZON Study. Should you decide to participate, you would identify which of your adult patients meet the provided inclusion/exclusion criteria and discuss the opportunity with them to participate at the nearby study site. Patients will undergo formal study screening with the Principal Investigator to determine eligibility.
Compensation at fair market value will be provided to HCPs who participate and meet program requirements.
The Effectus Patient Identification and Consultation Program
Effectus Patient Identification and Consultation Program Overview
Support Provided
Effectus will be your trusted partner throughout your participation, helping to facilitate your patients throughout the screening process and thus relieving the burden on your practice. If you wish to participate, you will be asked to review and sign a Services Agreement with Effectus, which outlines your program responsibilities and compensation. Participation is completely voluntary, and you can opt out at any time. Background on the study, program materials, and program logistics will be reviewed in detail during a 1-hour virtual training session, for which you will be compensated.
Why Participate?
NASH affects around 1 in 20 people or 5% of the world’s population and for many patients does not cause symptoms until it reaches advanced forms. In many countries there is no approved treatment for NASH. Fortunately, we can offer treatment options through clinical research studies for individuals suspected of having NASH. The onset of COVID-19 has resulted in a potential rise in cases of NASH as sedentary lifestyles lead to increased weight gain causing the worsening of chronic conditions such as diabetes, hypertension, and hypercholesterolemia, all potential driving forces of NASH. Participation in the Effectus Patient Identification and Consultation Program provides an opportunity to contribute to the research and advancement of a potential new treatment for NASH.
Sign a services
agreement.
Receive a package of
program materials and
complete a simple, 1-hour
virtual training session.
Utilize key screening
criteria to identify
potentially eligible
patients.
If the patient meets the criteria,
conduct a neutral consultation
about the availability of the
nearby study and gauge the
patient’s interest.
If the patient is interested in
participation, our team of dedicated
Patient Facilitators help ensure a
smooth patient transfer from your
office to the study.
The patient is scheduled
and presents at the study
site for the screening
appointment.
The patient’s enrollment
status is determined and is
relayed back to the treating
HCP by Effectus.
For more information on our program, please visit https://www.effectusctr.com/physician-network/.
The Effectus Patient Identification and Consultation Program
Contact Us
Montana Markell, Project Coordinator
Phone: 973-753-2430
Email: mmarkell@effectusctr.com