An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Phase 2

Completed

Brief Summary: An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

Recruitment & Eligibility

Inclusion Criteria

Male and female subjects 18 to 75 years of age
Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
Willing to provide signed informed consent

Exclusion Criteria

Treatment naïve acromegaly subjects
Prior treatment with paltusotine
Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
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
History of alcohol or substance abuse in the past 12 months
Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
Subjects with symptomatic cholelithiasis
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
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
Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

Arm && Interventions

Group	Intervention	Description
Paltusotine	Paltusotine	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level	13 Weeks	Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)	13 Weeks	The secondary endpoint was the proportion of participants who maintained IGF-1 response, defined as the last assessment before the EoT with IGF-1 ≤1.0× ULN meet responder criteria, in Group 3, 4, and 5 subjects only at W13/EoT
Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN	13 Weeks	Proportion of participants with IGF-1 ≤1.5× ULN at W13/EoT.

Locations (26): UCLA Gonda Diabetes Center
🇺🇸
Los Angeles, California, United States
Northwestern University Feinberg School of Medicine
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
OHSU Northwest Pituitary Center
🇺🇸
Portland, Oregon, United States
Allegheny Endocrinology Associates
🇺🇸
Pittsburgh, Pennsylvania, United States
CETI - Centro de Estudos em Terapias Inovadoras
🇧🇷
Curitiba, Brazil
Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
🇧🇷
Rio De Janeiro, Brazil
CPQuali Pesquisa Clinica
🇧🇷
São Paulo, Brazil
LMU Clinic of University of Munich
🇩🇪
Munich, Germany
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UCLA Gonda Diabetes Center
🇺🇸Los Angeles, California, United States