Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT07037420
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report
* Must be receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs (octreotide or lanreotide LAR) and meet both of the following:
1. Received for ≥ 6 months prior to screening
2. Receiving a once-monthly regimen (approximately every 4 weeks). Note: participants on stable regimens of other durations (for example, every 3 or 6 weeks) are not eligible
* Must be a partial responder to SSAs defined as \> 20% relative IGF 1 reduction during the course of SSA therapy
* Serum IGF-1 levels \> 1.3 to 5\*ULN inclusive, as assessed at a central laboratory and adjusted for age and sex, based on average of 2 consecutive values obtained during the Screening Period and obtained ≥ 7 days apart
Exclusion Criteria:
* Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study
* Pituitary adenoma that, per Investigator's judgment, is worsening as assessed by pituitary/sellar MRI or computed tomography scan obtained ≤ 6 months prior to screening
* Pituitary adenoma causing compression of the chiasm
* Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists
* Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or glucocorticoid hormone replacement therapy for ≥ 3 months prior to Screening
* Active, clinically significant cardiac disease as judged by the Investigator
* History of unstable angina, stroke, or acute myocardial infarction ≤ 3 months prior to screening
* Known uncontrolled type 2 diabetes (HbA1c \> 10%)
* Active malignant disease ≤ 2 years prior to screening with exception of basal and squamous cell carcinoma of the skin
* Received any type of fractionated radiotherapy or a second surgical adenectomy for pituitary adenoma within the last 3 years (5 years for conventional radiation) before starting treatment and/or are planning to receive radiotherapy or a second surgical adenectomy during the study
* Received pegvisomant ≤ 8 weeks prior to screening
* Received dopamine agonists ≤ 4 weeks prior to screening
* Received pasireotide LAR ≤ 4 months prior to screening
* Clinically significant renal or hepatic disease at the time of screening, as judged by the Investigator
* eGFR (CKD-EPI formula) \< 30 mL/minute/1.73 m\^2 documented based on recent value (\< 3 months prior to randomization)
* Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis, as judged by the Investigator, including, but not limited to, total bilirubin \> 1.5\*ULN (except if in free bilirubin linked to a known Gilbert Syndrome) or AST, ALT, or alkaline phosphatase \> 2\*ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07037420
Study Brief:
Protocol Section:
NCT07037420