An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
An open label exploratory study designed to evaluate the safety, efficacy, and
 pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin
 receptor type 2 biased agonist) in subjects with acromegaly that are treated with
 somatostatin analogue (SSA) based treatment regimens.
Inclusion Criteria:

 1. Male and female subjects 18 to 70 years of age

 2. Confirmed diagnosis of acromegaly with either a partial or complete response to
 protocol defined somatostatin analogue therapy regimens

 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 6 months prior to Screening. Subjects receiving radiation
 therapy may be eligible with some restrictions.

 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. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C
 antibody (HCV-Ab) or has a history of a positive result

 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,
 and 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 taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a
 dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg

 13. Subjects who usually take octreotide LAR or lanreotide depot less frequently than
 every 4 weeks (e.g. every 6 weeks or 8 weeks)