Ersodetug for Hyperinsulinism

(tHI Trial)

Overseen By Rezolute Clinical Trial

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rezolute

Disqualifiers: Active infection, Organ condition, Others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that significant changes to standard medical treatments for hypoglycemia should not occur within 4 weeks of screening or during the study. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug Ersodetug for hyperinsulinism?

The research on GLP-1 receptor agonists, similar to Ersodetug, shows they can help control blood sugar by increasing insulin secretion and reducing glucagon (a hormone that raises blood sugar) output. These drugs also help with weight loss and have been effective in managing type 2 diabetes, suggesting potential benefits for hyperinsulinism. ^{1 2 3 4 5}

How does the drug Ersodetug differ from other treatments for hyperinsulinism?

The research does not provide specific information about how Ersodetug differs from other treatments for hyperinsulinism. ^{6 7 8 9 10}

What is the purpose of this trial?

The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug for treatment of hypoglycemia in patients with Tumor-Associated Hyperinsulinism (tHI).

Eligibility Criteria

Adults over 18 with Tumor-Associated Hyperinsulinism (tHI) who often have low blood sugar despite standard treatments and surgery. They must be evaluated by a team including an oncologist and experience at least 3 significant hypoglycemia events weekly.

Inclusion Criteria

My eligibility was reviewed by a team of cancer specialists.

I am in a group receiving a hidden treatment as part of my study.

I experience 3 or more serious low blood sugar events weekly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive either ersodetug or placebo for 8 weeks

8 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with ersodetug long-term

up to 3 years

Treatment Details

Interventions

• Ersodetug

Trial Overview The trial is testing Ersodetug, a new medication for managing low blood sugar in patients with tHI, against a placebo to see if it's effective and safe. Participants are randomly assigned to receive either the drug or placebo.

Participant Groups

Group I: Open-Label Hospitalized Participants Experimental Treatment 1 Intervention

Group II: Double Blind Ambulatory Participants Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Rezolute

Lead Sponsor

Trials

4

Recruited

230+

References

1. France pubmed.ncbi.nlm.nih.gov

Incretin-based therapy in combination with basal insulin: a promising tactic for the treatment of type 2 diabetes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

When oral agents fail: optimizing insulin therapy in the older adult. [2011]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Exenatide and liraglutide: different approaches to develop GLP-1 receptor agonists (incretin mimetics)--preclinical and clinical results. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

The rationale for combining GLP-1 receptor agonists with basal insulin. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Management of the T2D Patient With High A1C. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

[Endogenous hyperinsulinism: review and follow-up of 24 cases]. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Practical management of hyperinsulinism in infancy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Management of hyperinsulinism in infancy and childhood. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

The management of islet cell dysregulation syndromes in infancy and childhood. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

Endogenous hyperinsulinism. [2004]