Octreotide subcutaneous depot for acromegaly: A randomized, double-blind, placebo-controlled phase 3 trial, ACROINNOVA 1

Acromegaly, characterized by excessive growth hormone (GH) and insulin-like growth factor-1 (IGF-1), impacts quality of life (QoL) and mortality. Standard of care (SoC; octreotide long-acting repeatable or lanreotide autogel) treatment typically requires healthcare provider administration. CAM2029,...

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Published in:The journal of clinical endocrinology and metabolism 2024-10
Main Authors: Ferone, Diego, Freda, Pamela, Katznelson, Laurence, Gatto, Federico, Kadioğlu, Pinar, Maffei, Pietro, Seufert, Jochen, Silverstein, Julie M, Spencer-Segal, Joanna L, Isaeva, Elena, Dreval, Alexander, Harrie, Maria, Svedberg, Agneta, Tiberg, Fredrik
Format: Article
Language:English
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Summary:Acromegaly, characterized by excessive growth hormone (GH) and insulin-like growth factor-1 (IGF-1), impacts quality of life (QoL) and mortality. Standard of care (SoC; octreotide long-acting repeatable or lanreotide autogel) treatment typically requires healthcare provider administration. CAM2029, a novel subcutaneous octreotide depot with increased bioavailability using FluidCrystal technology, enables self-administration and room-temperature storage. Assess superiority of CAM2029 versus placebo for biochemical control in patients with controlled acromegaly. 24-week, multinational, randomized, double-blind, phase 3 trial (NCT04076462). 45 sites; ten countries. 72 patients on SoC with biochemical control at screening (IGF-1 ≤upper limit of normal [ULN]; mean GH
ISSN:0021-972X
1945-7197
1945-7197
DOI:10.1210/clinem/dgae707