An open label, long-term extension study to evaluate the safety and efficacy of CRN00808 in subjects with acromegaly (ACROBAT ADVANCE)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511921-75-00

Acronym

CRN00808-05

Enrollment

Registered

2024-07-23

Start date

2020-02-19

Completion date

Unknown

Last updated

2025-07-29

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

Conditions

Acromegaly

Brief summary

1. The primary endpoint is the incidence of treatment-emergent AEs (TEAEs) throughout the study.

Detailed description

1. Change from the W16 visit (15 weeks of study treatment) in IGF-1 levels, 2. Change from W16 in growth hormone (GH) levels;

Interventions

DRUGPaltusotine tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. The primary endpoint is the incidence of treatment-emergent AEs (TEAEs) throughout the study.	—

Secondary

Measure	Time frame
1. Change from the W16 visit (15 weeks of study treatment) in IGF-1 levels, 2. Change from W16 in growth hormone (GH) levels;	—

Countries

Germany, Greece, Hungary

Outcome results

None listed

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