ALXN2420 + Somatostatin Analogs for Acromegaly

(ASTERIA Trial)

This trial tests a new treatment called ALXN2420 for individuals with acromegaly, a condition characterized by excessive growth hormone production, leading to enlarged bones and tissues. The study aims to determine if ALXN2420, when combined with existing treatments, can reduce levels of IGF-1, a hormone often elevated in acromegaly. Participants will receive either ALXN2420 or a placebo for 15 weeks, after which everyone will have the option to receive ALXN2420 for an additional period. Ideal candidates have maintained a stable regimen of somatostatin analogs (a type of medication) for at least 6 months and continue to experience symptoms despite treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

You must continue taking your current somatostatin analog (SSA) medication, as the trial requires participants to be on a stable dose of SSAs. The protocol does not specify stopping other medications, but certain medications like pegvisomant and dopamine agonists must not have been taken recently before the trial.

Research shows that ALXN2420 is a new treatment under testing for acromegaly, a condition characterized by excessive growth hormone production. Earlier studies have combined it with current treatments to evaluate its efficacy and safety. ALXN2420 blocks the growth hormone receptor, potentially helping to control hormone levels.

Unlike the standard of care for acromegaly, which typically involves somatostatin analogs, ALXN2420 is a novel treatment that researchers are excited about because it offers potentially improved outcomes. ALXN2420 is administered via subcutaneous injection, which can be more convenient for patients compared to other methods. This treatment may provide a new mechanism of action, targeting pathways that current therapies do not, possibly leading to better control of the condition.

In this trial, participants will receive ALXN2420, which previous studies have shown to lower levels of a substance called IGF-1 in animals like rats and dogs. This suggests it might help people with acromegaly, a condition where the body produces too much growth hormone. ALXN2420 blocks the action of growth hormone, reducing IGF-1 levels. Other research indicates that combining ALXN2420 with somatostatin analogs (drugs that also reduce growth hormone) may enhance its effectiveness. These findings support further research into ALXN2420 as a treatment option for acromegaly.¹²³⁴⁵