RecruitingPHASE3INTERVENTIONAL

A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

This research study is investigating a new medication called Ersodetug for adults living with Tumour Hyperinsulinism (Tumour HI). This is a rare condition where non-removable tumours cause the body to produce too much insulin or similar hormones, leading to dangerously low blood sugar levels (hypoglycaemia) that can't be well-managed with current treatments. The study aims to look at how well Ersodetug works alongside usual care, its safety, and if people can tolerate it. Participants will receive weekly doses of Ersodetug for 8 weeks. Researchers hope this study will identify a new way to help manage this challenging condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Rezolute

Enrolment target

Start

16 Apr 2025

Estimated completion

01 Sep 2027

Tumor Hyperinsulinism (Tumor HI)

What is this study about?

This research study is looking into a new medication called Ersodetug. It's designed for people who have a rare condition called Tumour Hyperinsulinism, often shortened to Tumour HI. This condition means that certain tumours in the body produce too much of a hormone like insulin, which then causes very low blood sugar levels. These low blood sugar levels can be quite severe and are often hard to control with the treatments currently available.

The main goal of this study is to see if Ersodetug, when added to your usual treatments, can help to effectively manage these low blood sugar levels. Researchers will also be carefully checking for any side effects and how well people tolerate the medication. Ultimately, the hope is that this study will help find a better way to treat people with Tumour HI whose symptoms aren't well controlled by existing therapies.

This is a 'Phase 3' study, which means it's one of the final stages of testing a new medicine before it might become more widely available. It involves a small number of participants across a few countries, reflecting the rarity of the condition. Your participation would be highly valuable in helping us understand if Ersodetug could be a useful new treatment option.

Key takeaways

This study is for adults with Tumour Hyperinsulinism.
It's testing a new drug, Ersodetug, for low blood sugar.
Participants take weekly doses of Ersodetug for 8 weeks.
It’s for those whose low blood sugar isn't well-controlled.
A team of specialists will decide if it's right for you.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over. You must have been diagnosed with Tumour Hyperinsulinism, meaning you have a tumour that causes too much insulin-like hormones, leading to low blood sugar. Importantly, your current treatments must not be successfully controlling these low blood sugar levels, and you must have needed a drip for sugar into your vein for at least 7 days recently because your blood sugar was so low.

There are also some reasons why you might not be able to join. For example, if you have certain active infections like HIV or hepatitis, or if you've recently taken part in another drug trial. If you have severe heart, liver, or kidney problems, or certain mental health conditions, these might also prevent you from participating. You also cannot be allergic to Ersodetug or any of its ingredients.

Ultimately, a team of specialist doctors, including an oncologist (a cancer specialist), will review your medical information to decide if this study is right for you and if it's safe for you to take part, considering your overall health and medical history.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Tumour Hyperinsulinism?
Are your low blood sugar levels from this condition not well-controlled by current treatments?
Have you recently needed and received a sugar solution (glucose) through an IV drip for at least 7 days due to very low blood sugar?
Do you have any severe heart, liver, or kidney problems, or active infections like HIV or hepatitis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve several stages. First, there's a 'screening' period, which can last up to 4 weeks. During this time, you'll have tests and checks to make sure the study is suitable and safe for you.

If you're eligible, you'll then enter the 'treatment' period, which lasts for 8 weeks. During this time, you'll receive doses of Ersodetug every week, alongside your usual treatments for low blood sugar. The dose of Ersodetug will be 9 mg for every kilogram of your body weight.

After the 8 weeks of treatment, there are two possibilities. You might enter an 'End of Study Follow-up' period, which lasts for about 20 weeks after your last dose, where doctors will monitor your health. Alternatively, you might have the option to join an 'Open Label Extension' phase, which could last for up to 3 years. This phase allows eligible participants to continue receiving the study medication for a longer period. Throughout the study, you'll have visits and assessments to monitor your health and how you're responding to the treatment.

Potential risks and benefits

Taking part in a clinical study offers the potential benefit of accessing a new treatment before it's widely available, which might help manage your low blood sugar levels if current therapies aren't working well. However, all medications carry potential risks, and Ersodetug may have side effects that are not yet fully known. These will be carefully monitored throughout the study. You will be fully informed of any known risks, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Investigative Site
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Chicago, United States· Recruiting
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Bethesda, United States· Not yet recruiting
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Boston, United States· Recruiting
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Rochester, United States· Recruiting
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New York, United States· Recruiting
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Canton, United States· Recruiting
Investigative Site
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Portland, United States· Recruiting
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Houston, United States· Not yet recruiting
Investigative Site
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Clichy, France· Recruiting
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Rotterdam, Netherlands· Recruiting
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Basel, Switzerland· Recruiting
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Unverified
Saint Johns Wood, United Kingdom· Recruiting

Common questions

What is Tumour Hyperinsulinism?

It's a rare condition where certain tumours make too much insulin or similar hormones, causing dangerously low blood sugar levels.

What is Ersodetug?

Ersodetug is the new medication being tested in this study to see if it can help control low blood sugar in people with Tumour HI.

How long will the study last if I take part?

The main treatment part is 8 weeks, but including screening and follow-up, it could last from about 5 to 6 months, or up to 3 years if you join the optional extended phase.

Will I still take my usual medicines?

Yes, Ersodetug will be given in addition to your current treatments for low blood sugar.

What happens if I decide I don't want to continue the study?

You can leave the study at any point, and it won't affect your ongoing medical care.

How to find out more

Rezolute Clinical Trial

clinicaltrials@rezolutebio.com 650-206-4507 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.