A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Non-pharmacologically Treated Acromegaly (PATHFNDR-2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511924-15-00

Acronym

CRN00808-08

Enrollment

Registered

2024-09-19

Start date

2022-04-29

Completion date

Unknown

Last updated

2025-11-11

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 achieve 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 who achieve IGF-1 <1.3×ULN at EOR., Proportion of subjects with GH <1 ng/mL at Week 22., 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 achieve 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 who achieve IGF-1 <1.3×ULN at EOR., Proportion of subjects with GH <1 ng/mL at Week 22., Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR.	—

Countries

Bulgaria, France, Germany, Greece, Hungary, Italy, Poland

Outcome results

None listed

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