A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)
A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is 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 responders to octreotide LAR or lanreotide depot.
Inclusion Criteria:

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

 2. Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR
 or lanreotide depot

 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 or radiation therapy at any time
 prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more
 than 4 years prior to study entry) with recently documented elevated IGF-1 may be
 eligible.

 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 who have been taking the following prior medications: pegvisomant (within the
 last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR
 (within the last 6 months)

 13. Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a
 dose higher than 120 mg

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