The Journal of clinical endocrinology and metabolism · 2025
Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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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
Аннотация
CONTEXT: 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.
OBJECTIVE: Assess superiority of CAM2029 vs placebo for biochemical control in patients with controlled acromegaly.
DESIGN: 24-week, multinational, randomized, double-blind, phase 3 trial (NCT04076462).
SETTING: 45 sites; 10 countries.
PATIENTS: 72 patients on SoC with biochemical control at screening [IGF-1 ≤upper limit of normal (ULN); mean GH <2.5 μg/L].
INTERVENTIONS: Patients were randomized 2:1 to once-monthly CAM2029 (n = 48) or placebo (n = 24).
MAIN OUTCOME MEASURES: The primary endpoint was proportion of patients with IGF-1 ≤ULN (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 ≤ULN (week 22/24) and mean GH <2.5 μg/L (week 24).
RESULTS: 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.
CONCLUSION: 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.
CLINICAL TRIAL REGISTRATION: NCT04076462 (ClinicalTrials.gov).
OBJECTIVE: Assess superiority of CAM2029 vs placebo for biochemical control in patients with controlled acromegaly.
DESIGN: 24-week, multinational, randomized, double-blind, phase 3 trial (NCT04076462).
SETTING: 45 sites; 10 countries.
PATIENTS: 72 patients on SoC with biochemical control at screening [IGF-1 ≤upper limit of normal (ULN); mean GH <2.5 μg/L].
INTERVENTIONS: Patients were randomized 2:1 to once-monthly CAM2029 (n = 48) or placebo (n = 24).
MAIN OUTCOME MEASURES: The primary endpoint was proportion of patients with IGF-1 ≤ULN (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 ≤ULN (week 22/24) and mean GH <2.5 μg/L (week 24).
RESULTS: 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.
CONCLUSION: 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.
CLINICAL TRIAL REGISTRATION: NCT04076462 (ClinicalTrials.gov).