Brief Title
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
Official Title
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 (PATHFNDR-1)
Brief Summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
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 Outcome
Change from baseline in IGF-1 to EOR
Condition
Acromegaly
Intervention
Paltusotine
Study Arms / Comparison Groups
Paltusotine
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
52
Start Date
May 12, 2021
Completion Date
June 2025
Primary Completion Date
June 2023
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects ≥18 years of age 2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 833-827-9741, [email protected]
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT04837040
Organization ID
CRN00808-09
Secondary IDs
2020-005431-70
Responsible Party
Sponsor
Study Sponsor
Crinetics Pharmaceuticals Inc.
Study Sponsor
, ,
Verification Date
June 2022