A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Acromegaly Treated with Long-acting Somatostatin Receptor Ligands

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511925-71-00

Acronym

CRN00808-09

Enrollment

Registered

2024-09-11

Start date

2021-08-05

Completion date

Unknown

Last updated

2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Brief summary

Proportion of subjects who maintain biochemical response in IGF-1 (≤1.0×the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)

Detailed description

Change from baseline in IGF-1, in units of ULN, to EOR, Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at baseline, Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR

Interventions

DRUGPlacebo to match paltusotine tablets 20 mg

DRUGPaltusotine tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who maintain biochemical response in IGF-1 (≤1.0×the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)	—

Secondary

Measure	Time frame
Change from baseline in IGF-1, in units of ULN, to EOR, Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at baseline, Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR	—

Countries

Belgium, Bulgaria, France, Hungary, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026