Trial reportThe Journal of clinical endocrinology and metabolism2024
Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine.
Trial report in The Journal of clinical endocrinology and metabolism, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of pharmacologic therapies in acromegaly: a systematic literature review and network meta-analysis.The Journal of clinical endocrinology and metabolism · 2026Pooled it
- Trial
- Rapid and Sustained Response of Biochemically Uncontrolled Acromegaly to Once-daily Oral Paltusotine Treatment.The Journal of clinical endocrinology and metabolism · 2026Trial
- Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1.The Journal of clinical endocrinology and metabolism · 2025Trial
- Symptom severity and exacerbation frequency in medically treated patients with acromegaly.Pituitary · 2026Article
- Phase 1 Study of Paltusotine, a Novel Oral Once‑Daily, Nonpeptide Selective Somatostatin Receptor 2 Agonist, in Healthy Japanese Adults.Clinical pharmacology in drug development · 2026Article
- What is the future of acromegaly therapy?The Journal of clinical endocrinology and metabolism · 2026Review
- Acromegaly complications: an update.The Journal of clinical endocrinology and metabolism · 2026Review
- Current treatment landscape of acromegaly.The Journal of clinical endocrinology and metabolism · 2026Review
- The acromegaly patient experience: burden of treatment and quality of life.The Journal of clinical endocrinology and metabolism · 2026Review
- Current controversies in acromegaly care.The Journal of clinical endocrinology and metabolism · 2026Review
- Review
- Review
- Paltusotine: The first FDA approved oral treatment for acromegaly.Annals of medicine and surgery (2012) · 2026Article
- Paltusotine: First Approval.Drugs · 2026Review
- Proteoformics-driven new concept of human growth hormone in clinical endocrinology.Frontiers in endocrinology · 2026Review
- A new era in oral treatment for acromegaly with the FDA-approved drug paltusotine.Annals of medicine and surgery (2012) · 2026Article
- Phenotypic and functional characteristics of pituitary adenoma stem cells.World journal of clinical cases · 2025Article
- Real-world burden of disease, treatment, and healthcare resource utilization in acromegaly: a quantitative survey of patient experiences.Journal of patient-reported outcomes · 2025Article
- Oral paltusotine, a nonpeptide selective somatostatin receptor 2 agonist: Mass balance, absolute bioavailability and metabolism in healthy participants.British journal of clinical pharmacology · 2025Article
Corrections and comments
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Authors and funding
19 authors.
Funding
Abstract
contextPaltusotine is a nonpeptide selective somatostatin receptor 2 agonist in development as once-daily oral treatment for acromegaly.
objectiveTo evaluate the efficacy and safety of paltusotine in the treatment of patients with acromegaly previously controlled with injected somatostatin receptor ligands (SRLs).
methodsThis phase 3, randomized, double-blind, placebo-controlled trial enrolled adults with acromegaly who had IGF-I ≤1.0 times the upper limit of normal (×ULN) while receiving a stable dose of depot octreotide or lanreotide. Patients were switched from injected SRLs and randomized to receive paltusotine or placebo orally for 36 weeks. The primary endpoint was proportion of patients maintaining IGF-I ≤1.0× ULN. Secondary endpoints were change in IGF-I level, change in Acromegaly Symptom Diary score, and maintenance of mean 5-sample GH <1.0 ng/mL.
resultsThe primary endpoint was met: 83.3% (25/30) of patients receiving paltusotine and 3.6% (1/28) receiving placebo maintained IGF-I ≤1.0× ULN (odds ratio, 126.53; 95% CI, 13.73->999.99; P < .0001). Paltusotine was also superior to placebo for all secondary endpoints: mean (± SE) change in IGF-I of 0.04 ± 0.09× ULN vs 0.83 ± 0.1× ULN (P < .0001); mean (± SE) change in Acromegaly Symptom Diary score of -0.6 ± 1.5 vs 4.6 ± 1.6 (P = .02); mean GH maintained at <1.0 ng/mL in 20/23 (87.0%) vs 5/18 (27.8%) patients (odds ratio, 16.61; 95% CI, 2.86-181.36; P = .0003). The most common adverse events were acromegaly symptoms and gastrointestinal effects characteristic of SRLs.
conclusionReplacement of injected SRLs by once-daily oral paltusotine was effective in maintaining both biochemical and symptom control in patients with acromegaly and was well tolerated.
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