A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)
- Registration Number
- NCT03792555
- Lead Sponsor
- Crinetics Pharmaceuticals Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- Male and female subjects 18 to 70 years of age
- Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot
- 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 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.
- 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 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)
- Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Paltusotine Paltusotine - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of subjects who meet responder criteria (based on the mean of two consecutive insulin-like growth factor-1 [IGF-1] measurements ≤ upper limit of normal [ULN]) 13 Weeks
- Secondary Outcome Measures
Name Time Method Change in patient assessed symptoms of acromegaly From Week 10 to Week 13 Total score computed by adding each of the individual acromegaly symptom intensities (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, numbness or tingling).
Change in IGF-1 levels From Week 10 to Week 13 Change in growth hormone (GH) levels From Week 8 to Week 13
Trial Locations
- Locations (45)
National Institute of Endocrinology "C. I. Parhon"
🇷🇴Bucharest, Romania
Centrum Nowoczesnch Terapii "Dobry Lekarz"
🇵🇱Kraków, Poland
National Institute of Endocrinology and Diabetology
🇸🇰Ľubochňa, Slovakia
Military Health Center, Division of Endocrinology
🇭🇺Budapest, Hungary
Semmelweis University Faculty of Medicine
🇭🇺Budapest, Hungary
Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
🇵🇱Krakow, Poland
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
CETI - Centro de Estudos em Terapias Inovadoras
🇧🇷Curitiba, Brazil
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
General Hospital of Athens "Evangelismos"
🇬🇷Athens, Greece
LMU Clinic of University of Munich
🇩🇪Munich, Germany
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
OHSU Northwest Pituitary Center
🇺🇸Portland, Oregon, United States
Keck Medical Center of USC University of Southern California
🇺🇸Los Angeles, California, United States
General Hospital of Athens "Laiko"
🇬🇷Athens, Greece
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
🇧🇷Rio De Janeiro, Brazil
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
General Hospital of Athens "Gennimatas"
🇬🇷Athens, Greece
MEDICOVER Neuroendokrinologie
🇩🇪München, Germany
General Hospital of Athens "Ippokratio"
🇬🇷Thessaloníki, Greece
Barts and the London School of Medicine
🇬🇧London, United Kingdom
Endocrine, Diabetes and Research Centre, Wellington Hospital
🇳🇿Wellington, New Zealand
University of Pécs Medical School
🇭🇺Pécs, Hungary
Emergency Clinical County Hospital, Endocrinology Clinic
🇷🇴Cluj-Napoca, Romania
Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
🇷🇸Belgrade, Serbia
Waitemata District Health Board, North Shore Hospital
🇳🇿Takapuna, New Zealand
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
The Centre of Postgraduate Medical Education
🇵🇱Warsaw, Poland
Clinical Centre of Vojvodina, Clinic for Endocrinology, Diabetes and Metabolic Diseases
🇷🇸Novi Sad, Serbia
University Hospital Bratislava
🇸🇰Bratislava, Slovakia
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Universita Vita-Salute San Raffaele
🇮🇹Milano, Italy
Salford Royal NHS Foundation Trust
🇬🇧Salford, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
CPQuali Pesquisa Clinica
🇧🇷São Paulo, Brazil
Royal Brisbane & Women's Hospital
🇦🇺Herston, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Australia
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Allegheny Endocrinology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Keogh Institute for Medical Research
🇦🇺Nedlands, Australia
UCLA Gonda Diabetes Center
🇺🇸Los Angeles, California, United States
University Hospitals Coventry and Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom