Announcing the upLIFT Clinical Study for Patients with Low Blood Sugar due to Certain Types of Tumors (Tumor Hyperinsulinism)

Tumor hyperinsulinism (tumor HI) is a rare condition where certain types of tumors produce too much insulin or similar proteins, causing frequent and dangerously low blood sugar levels (hypoglycemia). This can make it hard for people with tumor HI to stay healthy enough to continue their cancer treatments.

The upLIFT study is a phase 3 clinical trial that is testing whether or not a new therapy, called ersodetug, can safely reduce hypoglycemia in adults with tumor HI. This study is open to people 18 and older who have a type of tumor that causes tumor HI and are still experiencing frequent, serious low blood sugar levels, even with standard treatment.

upLIFT is more than a study—it’s the potential to elevate treatment options and improve the lives of those living with tumor HI.

About tumor HI

In tumor HI, certain tumors (lumps or abnormal cell growths) in the pancreas or other parts of the body make too much insulin or a similar protein called insulin-like growth factor-2 (IGF-2). These proteins affect insulin receptors, which usually work to carefully control blood sugar levels. When there’s too much insulin or IGF-2, the body lowers blood sugar too much, leading to frequent, potentially dangerous episodes of hypoglycemia.

People with tumor HI need treatment to prevent serious health problems and help them feel better each day. Managing blood sugar is especially important so they can continue getting the right care for their tumor.

About Ersodetug

Ersodetug has been specifically developed to treat multiple forms of hyperinsulinism. It is a type of medicine called a monoclonal antibody—meaning it is a protein created in a research laboratory that can act like the body’s own targeting system to work at a very specific point inside the body. Different monoclonal antibodies have already provided breakthrough treatments in many health conditions.

Ersodetug targets the insulin receptor to turn down insulin’s signal to take sugar from the bloodstream, which is particularly helpful to keep the sugar levels in a safer range to give the body and brain the right amount of fuel to work as they should.

Ersodetug is given intravenously (small tube placed into a vein, also called an IV). It takes approximately 30 minutes for the medicine to get through the IV and into the body. The amount of ersodetug given depends on a participant’s weight.

About the upLIFT Study


PHASE:

3

ESTIMATED
ENROLLMENT:

48

Because of the significant unmet treatment needs of patients living with tumor HI, researchers are looking for better ways to care for people with tumor HI. Clinical studies like upLIFT are essential to discovering new treatment options.

The upLIFT study is being done to see if adding ersodetug to standard medicines (also called “standard‑of‑care” or SOC) helps in controlling blood sugar levels among people with tumor HI. The study is also investigating other effects ersodetug may have in the body, and the impact ersodetug may have on the daily lives of participants.

If you are eligible to participate, you will be enrolled into a specific treatment group depending on the type of tumor and if you are hospitalized or not. Not everyone enrolled in the study will be assigned to receive the study drug.

One part of this study is “double-blind,” meaning you and the Study Doctor will not know whether you are receiving the study drug, or a placebo (a substance that looks like the study drug but does not contain active drug). Participants will still receive their usual SOC treatments for their tumor HI.

The other part of the study is open-label, meaning it is known by the Study Doctor and the participant that the participant is receiving the study drug. Participants eligible for the open label are either those with an insulinoma causing severe hypoglycemia that requires the participant to be hospitalized, or those with tumors that make too much IGF-2.

Eligibility Criteria

You may be eligible for this study if you:

  • Have been diagnosed with tumor HI by your doctor

  • Have frequent hypoglycemia that is not responding to usual SOC

  • Are over the age of 18

  • Are willing to complete an evaluation involving medical tests and assessments

You are not eligible for this study if you:

  • Have active HIV, hepatitis B, or hepatitis C infection

  • Have a known allergy or sensitivity to ersodetug or any component of the drug

  • Recently participated in an investigational drug/device study within 30 days.

  • Are pregnant or breastfeeding

Additional inclusion and exclusion criteria may apply

What Will Happen in This Study

1. Screening Visit

If you are interested in joining this study, you will need to visit one of the study centers nearest your home.

A study doctor will explain the study to you. If you agree to join, the doctors and site staff will check your overall health, blood sugar levels, and other health conditions through simple tests. Study doctors will also ask you questions about your tumor HI symptoms, medical history, and medication history to make sure you are eligible to take part in the study. The screening period may last for up to 28 days.

If you meet all the criteria of the study and decide to join the study, you will continue your usually prescribed tumor HI treatment and be given either ersodetug or placebo.

2. Study Visit

Participants will visit the study center once per week for 8 weeks (Treatment Period) to receive the study drug and check on their health. Participants will receive 8 total doses of the study drug.

After participants receive the final dose of study drug in the Treatment Period, you will have the option to continue into the extended portion of the study and receive ersodetug for a longer period of time (up to 3 years).  If you choose to stop the study, you will return to the study center for one final follow-up visit 4 weeks after your last dose of study drug.

Frequently Asked Questions

  • You may or may not benefit from taking part in this study. The knowledge gained from this study may help doctors learn more about the study drug and this may help future participants. It is possible that the study drug may improve your hyperinsulinism. However, you may receive no medical benefit and the study drug may even be harmful to you.

  • The study drug, procedures, and devices will be made available to you at no charge.

    This study will require you to give up some of your time to make the planned study visits and may result in some extra travel costs compared with if you followed a standard treatment. You will be reimbursed the cost for travel to the study site, hotel and meals for the study and follow-up visits as well as other potential costs. Your Study Doctor can answer questions you may have about what costs may be covered.

  • Yes, you can. You are free to withdraw your consent and stop taking part in the study at any time without giving a reason.