A Randomized First-in-human Study of a Novel Growth Hormone Receptor Peptide Antagonist ALXN2420 in Healthy Subjects

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ID: 324571
2026
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Abstract
CONTEXT: Acromegaly is a rare disease typically caused by a growth hormone (GH) secreting pituitary adenoma. Somatostatin receptor ligand (SRL) monotherapy does not provide optimal control of circulating insulin-like growth factor-1 (IGF-1) levels in all patients with acromegaly. ALXN2420, a 16-amino acid peptide growth hormone receptor antagonist (GHRA), is being developed in combination therapy in patients with acromegaly insufficiently controlled with SRLs. OBJECTIVE: To evaluate the safety and tolerability (primary), pharmacokinetics and pharmacodynamics of ALXN2420 in healthy subjects. DESIGN: Phase 1, randomized, double-blind, placebo-controlled single- (SAD) and 2-week multiple ascending dose (MAD) studies. SETTING: : Single centre. PATIENTS: : Overall, 101 eligible and evaluable healthy subjects. INTERVENTION: : ALXN2420 or placebo. MAIN OUTCOME MEASUREMENTS: Safety assessments, pharmacokinetic parameters, serum IGF-1 levels. RESULTS: Subcutaneous injections of ALXN2420 up to 120 mg/day were well tolerated, with no safety concerns. Pharmacokinetic parameters increased dose proportionally. The terminal half-life was approximately 22 hours. ALXN2420 induced dose-related decreases in IGF-1 levels at doses ≥20 mg, with a more prolonged reduction at higher doses for up to 72 hours (SAD) and up to the end of treatment (MAD). Repeated daily ALXN2420 administration for 2 weeks suggested a cumulative effect compared to single administration. For ALXN2420 doses ≥40 mg, maximal mean changes from baseline versus placebo in IGF-1 levels ranged from approximately 20% to 30% (SAD) and 40% to 50% (MAD). CONCLUSION: ALXN2420 doses of up to 120 mg/day appeared to be safe and substantially decreased IGF-1 levels in healthy subjects, thereby supporting further testing in patients with acromegaly.
Reference Key
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Authors Soraya Allas, Guillaume Ravel, Colm Farrell, Thibaud Weiler, Sophie Fillon, Taha Ould Rouis, Michael D. Culler, Michel Ovize, Mark Sumeray, A. J. van der Lely
Journal european journal of endocrinology
Year 2026
DOI
10.1093/ejendo/lvag148
URL
https://doi.org/10.1093/ejendo/lvag148
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