"Debio-4126" for patients with Acromegaly currently taking octreotide ("Sandostatin" or "Mycapssa") or lanreotide ("Somatuline") with Dr. Luma Ghalib, MD.
Purpose
The purpose of this trial is to see if the study medication "Debio-4126" can safely maintain a low level of growth hormone ("GH") and insulin-like growth factor 1 ("IGF‑1") lab values for patients diagnosed with Acromegaly.
You will be asked to come to visits 1-2 times a month and receive an injection every 12 weeks at our clinic.
At clinic visits, you will be asked to answer questions about your medical history, speak to the study doctor, provide blood and urine samples, do ECGs and other imaging techniques, receive the study medication, and complete questionnaires. Not all of these will be done at every visit. Visits will take place at Outpatient Care East.
This study will use a computer to randomly assign you to the study medication ("Debio-4126") or a placebo, which has no therapeutic effect on the body, commonly referred to as a "sugar pill".
You have 5 chances out of 7 of receiving the study medication.
If you are assigned the placebo, you will have a chance to receive the study medication later in the study.
If you are eligible, your participation in this trial will last between 10 to 29 months depending on whether the trial drug is safe and works for you.
If you have any questions about this study, please don't hesitate to reach out to Hangil at 614-814-0809 or email at hangil.kim@osumc.edu.
Could this study be right for you?
Most Important Eligibility Criteria
- Over the age of 18 years old
- Have an official Acromegaly diagnosis
- Currently taking Octreotide or Lanreotide (ex. "Sandostatin", "Mycapssa", "Somatuline", etc...) at any dose for 6 months and on the same dose for the past 3 months.
- Controlled IGF-1 lab values
- Must not have had radiation on pituitary gland in the past
- Must not currently be taking pasireotide (Signifor), pegvisomant (Somavert), or dopamine agonists (Cabergoline)