New drug combo aims to tame acromegaly hormone levels
NCT ID NCT07037420
First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether adding ALXN2420 (a growth hormone blocker) to standard acromegaly treatment can lower IGF-1 levels more than placebo. About 60 adults with acromegaly who are already on a stable dose of somatostatin analogs will receive either ALXN2420 or placebo injections for 15 weeks. The main goal is to see if the drug reduces IGF-1 levels, a key marker of disease control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ALXN2420 (a growth hormone blocker)
- What this could lead to
- If it works, this could offer a new treatment option for people with acromegaly whose disease is not fully controlled by current therapy.
- What could go wrong
- This is an early phase 2 trial with only 60 participants, so results may not apply to everyone. The drug may not lower hormone levels enough or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
8 people
The number who actually took part.
- Started
-
Oct 2025
- Finished
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Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Torrance, California, 90502, United States
-
Research Site
Ann Arbor, Michigan, 48109, United States
-
Research Site
Pisa, 56126, Italy
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Research Site
Kaunas, LT50009, Lithuania
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Research Site
Vilnius, 09112, Lithuania
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Research Site
Bucharest, 011863, Romania
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New Long-Acting shot takes aim at Acromegaly's hormone overload
- Can a Once-Monthly shot tame Acromegaly's hormone overdrive?
- Can a Growth-Hormone blocker stay safe in everyday use? a korean study investigates
- Which intubation method works best for acromegaly patients?
- New octreotide pill faces off against current capsule in healthy volunteer study
- New software could improve acromegaly care