Loading clinical trials...

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

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)

NCT04837040•Crinetics Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female subjects ≥18 years of age
•2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
•3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
•4. Willing to provide signed informed consent

Exclusion Criteria

•1. Treatment naïve or treatment-withdrawn acromegaly subjects
•2. Prior treatment with paltusotine
•3. Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
•4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
•5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
•6. Known history of HIV, hepatitis B, or active hepatitis C
•7. History of alcohol or substance abuse in the past 12 months
•8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
•9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
•10. Subjects with symptomatic cholelithiasis
+2 more criteria

Locations (39)

Crinetics Study Site

Los Angeles, California, United States

Crinetics Study Site

Torrance, California, United States

Crinetics Study Site

Baltimore, Maryland, United States

Crinetics Study Site

Boston, Massachusetts, United States

Crinetics Study Site

Philadelphia, Pennsylvania, United States

Crinetics Study Site

Pittsburgh, Pennsylvania, United States

Crinetics Study Site

Nashville, Tennessee, United States

Crinetics Study Site

CABA, Buenos Aires, Argentina

Crinetics Study Site

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Crinetics Study Site

Córdoba, Argentina

Key Dates

Start Date

May 12, 2021

Primary Completion Date

July 10, 2023

Completion Date

June 1, 2027

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Acromegaly

Interventions

Paltusotine

DRUG

Placebo

DRUG

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

NCT00001595

PanhypopituitarismGigantism/Acromegaly+2 more

View study

COMPLETEDPHASE3

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

NCT04125836

Acromegaly

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

Inclusion Criteria

Exclusion Criteria

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly

Endocrine Cardiomyopathy: Response to Cyclic GMP PDE5 Inhibitors in Acromegaly Cardiomyopathy

Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients