A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
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.
Inclusion Criteria:

 1. Male and female subjects ≥18 years of age

 2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 <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 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

 11. Subjects with clinically significant abnormal findings during the Screening Period, or
 any other medical condition(s) or laboratory findings that, in the opinion of the
 Investigator, might jeopardize the subject's safety or ability to complete the study

 12. Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or
 pegvisomant, dopamine agonists, or short acting somatostatin analogs (with 12 weeks
 prior to Screening)