Trial reportThe Journal of clinical endocrinology and metabolism2026
Rapid and Sustained Response of Biochemically Uncontrolled Acromegaly to Once-daily Oral Paltusotine Treatment.
Trial report in The Journal of clinical endocrinology and metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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.
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Who cites it
10 citing papers in PubMed.
- Rapid and Sustained Response of Biochemically Uncontrolled Acromegaly to Once-daily Oral Paltusotine Treatment.The Journal of clinical endocrinology and metabolism · 2026Trial
- Article
- 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
- Current controversies in acromegaly care.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
- 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
- Functional profiling of somatostatin receptors identifies somatostatin receptor subtype 2 as a vulnerability in Succinate Dehydrogenase SDHB-deficient pheochromocytomas and paragangliomas.Molecular biomedicine · 2026Article
- A helical peptide antagonist of the human growth hormone receptor.Endocrinology · 2026Article
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Authors and funding
18 authors.
Funding
Abstract
contextPaltusotine is a nonpeptide, selective somatostatin receptor 2 agonist in development as once-daily oral treatment for acromegaly.
objectiveTo evaluate efficacy and safety of paltusotine in patients with biochemically uncontrolled acromegaly not currently receiving medical therapy.
methodsIn this phase 3, randomized, double-blind, placebo-controlled trial, adults with medically untreated acromegaly at randomization (stratum 1: medication-naïve or off acromegaly medications ≥4 months [IGF-I ≥ 1.3 × upper limit of normal {ULN}]; stratum 2: controlled on a somatostatin receptor ligand and underwent washout [IGF-I increase ≥30% to ≥1.1 × ULN]) received paltusotine or placebo for 24 weeks.
resultsA total of 111 patients (stratum 1, n = 82; stratum 2, n = 29) enrolled (paltusotine, n = 54; placebo, n = 57). The primary endpoint of IGF-I normalization at 24 weeks was met in 55.6% of paltusotine-treated patients vs 5.3% for placebo (odds ratio [OR]: 42.81; 95% CI, 8.44-455.82; P < .0001), with superiority to placebo in both strata. Paltusotine treatment decreased IGF-I in 92.6% of patients within the first 4 weeks. All secondary endpoints were met: mean (±SE) change in IGF-I of -0.82 ± 0.08×ULN with paltusotine vs 0.09 ± 0.08×ULN with placebo (P < .0001); IGF-I < 1.3×ULN in 66.7% vs 14.0% of patients (OR: 18.32; 95% CI, 5.64-79.16; P < .0001); GH (5-sample mean) < 1.0 ng/mL in 57.4% vs 17.5% (OR: 7.59; 95% CI, 2.78-23.48; P < .0001); mean (±SE) change in Acromegaly Symptom Diary score of -2.7 ± 1.4 vs 2.8 ± 1.4 (P = .004). Most adverse events were acromegaly symptoms or mild, transitory gastrointestinal effects characteristic of somatostatin receptor ligands (eg, diarrhea, abdominal pain). Pituitary tumor volume was stable or reduced in paltusotine-treated patients.
conclusionIGF-I normalized in significantly more patients with uncontrolled acromegaly treated with paltusotine vs placebo. Paltusotine was associated with rapid, sustained IGF-I reduction, significant symptom improvement and stable or reduced pituitary tumor size and was well tolerated.
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