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

Completed · Phase 2

Conditions studied: Acromegaly

In brief

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.

Key facts

Study ID

NCT03789656

Run by

Crinetics Pharmaceuticals Inc.

People needed

47

Starts

2019-03-12

Expected to finish

2020-08-31

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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
• General Hospital of Athens "Evangelismos" — Athens, Greece
• General Hospital of Athens "Gennimatas" — Athens, Greece
• General Hospital of Athens "Laiko" — Athens, Greece
• General Hospital of Athens "Ippokratio" — Thessaloniki, Greece
• Military Health Center, Division of Endocrinology — Budapest, Hungary
• Semmelweis University Faculty of Medicine — Budapest, Hungary
• University of Pécs Medical School — Pécs, Hungary
• Azienda Ospedaliera Universitaria Federico II — Naples, Italy
• Waitemata District Health Board, North Shore Hospital — Takapuna, New Zealand
• Endocrine, Diabetes and Research Centre, Wellington Hospital — Wellington, New Zealand
• Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow — Krakow, Poland
• National Institute of Endocrinology "C. I. Parhon" — Bucharest, Romania
• Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases — Belgrade, Serbia
• University Hospital Bratislava — Bratislava, Slovakia
• University Hospitals Coventry and Warwickshire NHS Trust — Coventry, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.