Trial reportThe Journal of clinical endocrinology and metabolism2023
ACROBAT Edge: Safety and Efficacy of Switching Injected SRLs to Oral Paltusotine in Patients With Acromegaly.
Trial report in The Journal of clinical endocrinology and metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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
21 citing papers in PubMed, 38 citations in OpenAlex.
- Rapid and Sustained Response of Biochemically Uncontrolled Acromegaly to Once-daily Oral Paltusotine Treatment.The Journal of clinical endocrinology and metabolism · 2026Trial
- Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine.The Journal of clinical endocrinology and metabolism · 2024Trial
- 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
- The acromegaly patient experience: burden of treatment and quality of life.The Journal of clinical endocrinology and metabolism · 2026Review
- A year in pharmacology: new drugs approved by the US food and drug administration in 2025.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Nitrogen-containing FDA-approved drugs in 2025: synthesis, significance and therapeutic applications.RSC advances · 2026Review
- Fluorine-containing FDA-approved small-molecule drugs in 2025: significance, synthetic insights, and therapeutic applications.RSC advances · 2026Review
- Paltusotine: First Approval.Drugs · 2026Review
- Phenotypic and functional characteristics of pituitary adenoma stem cells.World journal of clinical cases · 2025Article
- Consensus on acromegaly therapeutic outcomes: an update.Nature reviews. Endocrinology · 2025Review
- The clinical value of serum sST2 and cfDNA in guiding evidence-based nursing care for children with severe pneumonia complicated by myocardial damage.Journal of medical biochemistry · 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
- Review
- Differential Impact of Medical Therapies for Acromegaly on Glucose Metabolism.International journal of molecular sciences · 2025Review
- Advances in the Oral Administration of Somatostatin Receptor Ligands in Acromegaly: A Systematic Review Focusing on Biochemical Response.Pharmaceutics · 2024Review
- Medical treatment of functional pituitary adenomas, trials and tribulations.Journal of neuro-oncology · 2024Review
- Oral Octreotide Capsules and Paltusotine in Management of Acromegaly.TouchREVIEWS in endocrinology · 2024Review
- New Treatments for Acromegaly in Development.The Journal of clinical endocrinology and metabolism · 2024Article
- [What newly brought endocrinology by the past 2022?]Problemy endokrinologii · 2023Article
- Development and evaluation of the Acromegaly Symptom Diary.Journal of patient-reported outcomes · 2023Article
Corrections and comments
- Commented on by
Authors and funding
14 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextPaltusotine is a once-daily, oral, nonpeptide small-molecule somatostatin receptor type 2 (SST2) agonist in clinical development for treatment of acromegaly.
objectiveThis work aimed to evaluate change in insulin-like growth factor I (IGF-I) levels in patients switched from octreotide long-acting release or lanreotide depot monotherapy to paltusotine.
methodsA phase 2, open-label, prospective, multicenter, multinational, nonrandomized, single-arm exploratory study was conducted in which dosage uptitrations were performed in a double-blinded manner. At 26 global sites, patients with acromegaly switched to paltusotine from injected somatostatin receptor ligand (SRL)-based therapy. Patients received 13-week treatment with once-daily oral paltusotine (10-40 mg/d). The primary end point was change from baseline to week 13 in IGF-I for patients who switched from long-acting octreotide or lanreotide depot monotherapy to paltusotine (group 1). All patients underwent a 4-week paltusotine washout at end of treatment period (wk 13-17). IGF-I, growth hormone (GH), patient-reported outcome, and safety data were collected.
resultsForty-seven patients enrolled. In group 1 (n = 25), IGF-I and GH showed no significant change between SRL baseline and end of paltusotine treatment at week 13 (median change in IGF-I = -0.03×upper limit of normal [ULN]; P = .6285; GH = -0.05 ng/mL; P = .6285). IGF-I and GH rose significantly in the 4 weeks after withdrawing paltusotine (median change in IGF-I = 0.55×ULN; P < .0001 [median increase 39%]; GH = 0.72 ng/mL; P < .0001 [109.1% increase]). No patients discontinued because of adverse events (AE); no treatment-related serious AEs were reported.
conclusionThese results suggest once-daily oral paltusotine was effective in maintaining IGF-I values in patients with acromegaly who switched from injected SRLs. Paltusotine was well tolerated with a safety profile consistent with other SRLs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.