An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
- Registration Number
- NCT03789656
- Lead Sponsor
- Crinetics Pharmaceuticals Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Male and female subjects 18 to 70 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Paltusotine Paltusotine -
- Primary Outcome Measures
Name Time Method Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level 13 Weeks
- Secondary Outcome Measures
Name Time Method Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN 13 Weeks Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN) 13 Weeks
Trial Locations
- Locations (45)
Keck Medical Center of USC University of Southern California
🇺🇸Los Angeles, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
OHSU Northwest Pituitary Center
🇺🇸Portland, Oregon, United States
Keogh Institute for Medical Research
🇦🇺Nedlands, Australia
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Universita Vita-Salute San Raffaele
🇮🇹Milano, Italy
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Allegheny Endocrinology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Royal Brisbane & Women's Hospital
🇦🇺Herston, Australia
CETI - Centro de Estudos em Terapias Inovadoras
🇧🇷Curitiba, Brazil
Royal Melbourne Hospital
🇦🇺Melbourne, Australia
LMU Clinic of University of Munich
🇩🇪Munich, Germany
Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
🇧🇷Rio De Janeiro, Brazil
CPQuali Pesquisa Clinica
🇧🇷São Paulo, Brazil
MEDICOVER Neuroendokrinologie
🇩🇪München, Germany
General Hospital of Athens "Evangelismos"
🇬🇷Athens, Greece
General Hospital of Athens "Gennimatas"
🇬🇷Athens, Greece
General Hospital of Athens "Ippokratio"
🇬🇷Thessaloníki, Greece
Military Health Center, Division of Endocrinology
🇭🇺Budapest, Hungary
University of Pécs Medical School
🇭🇺Pécs, Hungary
Semmelweis University Faculty of Medicine
🇭🇺Budapest, Hungary
Waitemata District Health Board, North Shore Hospital
🇳🇿Takapuna, New Zealand
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Endocrine, Diabetes and Research Centre, Wellington Hospital
🇳🇿Wellington, New Zealand
Centrum Nowoczesnch Terapii "Dobry Lekarz"
🇵🇱Kraków, Poland
National Institute of Endocrinology "C. I. Parhon"
🇷🇴Bucharest, Romania
The Centre of Postgraduate Medical Education
🇵🇱Warsaw, Poland
Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
🇷🇸Belgrade, Serbia
University Hospital Bratislava
🇸🇰Bratislava, Slovakia
Salford Royal NHS Foundation Trust
🇬🇧Salford, United Kingdom
Barts and the London School of Medicine
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
UCLA Gonda Diabetes Center
🇺🇸Los Angeles, California, United States
General Hospital of Athens "Laiko"
🇬🇷Athens, Greece
Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
🇵🇱Krakow, Poland
Emergency Clinical County Hospital, Endocrinology Clinic
🇷🇴Cluj-Napoca, Romania
Clinical Centre of Vojvodina, Clinic for Endocrinology, Diabetes and Metabolic Diseases
🇷🇸Novi Sad, Serbia
National Institute of Endocrinology and Diabetology
🇸🇰Ľubochňa, Slovakia
University Hospitals Coventry and Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom