Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1
Primary result · IGF-1 ≤ULN responseResult — go to the resultRisk difference 34.6 95% CI 11.3–57.9Authors' 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.
Study context
- Population
- Patients with acromegaly on standard of care (SoC) (octreotide LAR or lanreotide autogel) with biochemical control at screening (IGF-1 ≤upper limit of normal (ULN); mean GH <2.5 μg/L); 45 sites, 10 countriesrandomized 2:1
- Participants
- 72 patients
- Comparison
- Once-monthly CAM2029 vs placebo
- CAM2029n = 48
- Placebon = 24reference
- Primary endpoint
- Proportion of patients with IGF-1 ≤ULN, with dose-reduced patients classified as nonresponders
- Follow-up
- Week 22/24 mean
Methodological detailsmultinational, double-blind, placebo-controlled, phase 3
- Multinational
- Double-blind
- Placebo-controlled
- Phase 3
Primary result
IGF-1 ≤ULN response · week 22/24
Risk difference
34.6
95% CI 11.3–57.9
P = 0.0018
By group
CAM2029vs Placebo
risk difference 34.6 (95% CI 11.3–57.9); P = 0.0018
As reported in the abstract
Secondary outcomes
Second key secondary endpoint: IGF-1 ≤ULN (week 22/24) and mean GH <2.5 μg/L (week 24) · intention-to-treat analysis
P = 0.0035
Symptoms, quality of life (QoL) and treatment satisfaction
- Well-controlled symptoms, improved QoL and treatment satisfaction with CAM2029 vs placebo and baseline
Safety
- CAM2029 was well tolerated; safety was consistent with SoC
Original publication
Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1. J Clin Endocrinol Metab. Published 8 October 2024. doi:10.
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