{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T19:49:59Z","timestamp":1792093799682,"version":"4.4.0"},"reference-count":46,"publisher":"The Endocrine Society","issue":"6","license":[{"start":{"date-parts":[[2024,10,8]],"date-time":"2024-10-08T00:00:00Z","timestamp":1728345600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Camurus AB","award":["NCT04076462"],"award-info":[{"award-number":["NCT04076462"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Acromegaly, characterized by excessive 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Assess superiority of CAM2029 vs placebo for biochemical control in patients with controlled acromegaly.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>24-week, multinational, randomized, double-blind, phase 3 trial (NCT04076462).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>45 sites; 10 countries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients<\/jats:title>\n                    <jats:p>72 patients on SoC with biochemical control at screening [IGF-1 \u2264upper limit of normal (ULN); mean GH &amp;lt;2.5\u2005\u03bcg\/L].<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Patients were randomized 2:1 to once-monthly CAM2029 (n = 48) or placebo (n = 24).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcome Measures<\/jats:title>\n                    <jats:p>The primary endpoint was proportion of patients with IGF-1 \u2264ULN (week 22\/24 mean), with dose-reduced patients classified as nonresponders; first key secondary endpoint was the same, including dose-reduced responders. The second key secondary endpoint was proportion of patients with IGF-1 \u2264ULN (week 22\/24) and mean GH &amp;lt;2.5\u2005\u03bcg\/L (week 24).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At week 22\/24 (intention-to-treat analysis), CAM2029-treated patients demonstrated superior response rates vs placebo for IGF-1 (72.2% vs 37.5%; risk difference: 34.6, 95% confidence interval: 11.3, 57.9; P = .0018) and combined IGF-1\/GH (70.0% vs 37.5%; P = .0035). CAM2029-treated patients had well-controlled symptoms, improved QoL, and treatment satisfaction vs placebo and baseline. CAM2029 was well tolerated; safety was consistent with SoC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>CAM2029 provides a convenient and effective treatment option for acromegaly, with superior biochemical control vs placebo. Symptom control, QoL, and satisfaction were improved from baseline SoC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>NCT04076462 (ClinicalTrials.gov).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgae707","type":"journal-article","created":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T07:22:37Z","timestamp":1728285757000},"page":"1729-1739","source":"Crossref","is-referenced-by-count":24,"title":["Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1"],"prefix":"10.1210","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1410-6143","authenticated-orcid":false,"given":"Diego","family":"Ferone","sequence":"first","affiliation":[{"name":"Endocrinology Unit, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino , 16131 Genova 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