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

Sponsor
Crinetics Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03789656
Collaborator
(none)
47
Enrollment
45
Locations
1
Arm
19.5
Actual Duration (Months)
1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge)
Actual Study Start Date :
Jan 15, 2019
Actual Primary Completion Date :
Aug 3, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paltusotine

Drug: Paltusotine
Paltusotine, capsules, once daily by mouth
Other Names:
  • CRN00808

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level [13 Weeks]

    Secondary Outcome Measures

    1. Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN) [13 Weeks]

    2. Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN [13 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    2. Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens

    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. Subjects receiving radiation therapy may be eligible with some restrictions.

    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 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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Keck Medical Center of USC University of Southern California Los Angeles California United States 90033
    2 UCLA Gonda Diabetes Center Los Angeles California United States 90095
    3 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    4 Johns Hopkins University Baltimore Maryland United States 21287
    5 Massachusetts General Hospital Boston Massachusetts United States 02114
    6 University of Michigan Ann Arbor Michigan United States 48106
    7 Cleveland Clinic Cleveland Ohio United States 44195
    8 Ohio State University Columbus Ohio United States 43210
    9 OHSU Northwest Pituitary Center Portland Oregon United States 97239
    10 Allegheny Endocrinology Associates Pittsburgh Pennsylvania United States 15212
    11 Research Institute of Dallas Dallas Texas United States 75231
    12 Royal Adelaide Hospital Adelaide Australia
    13 Royal Brisbane & Women's Hospital Herston Australia
    14 Royal Melbourne Hospital Melbourne Australia
    15 Keogh Institute for Medical Research Nedlands Australia
    16 CETI - Centro de Estudos em Terapias Inovadoras Curitiba Brazil
    17 Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia Rio De Janeiro Brazil
    18 CPQuali Pesquisa Clinica São Paulo Brazil
    19 LMU Clinic of University of Munich Munich Germany
    20 MEDICOVER Neuroendokrinologie München Germany
    21 General Hospital of Athens "Evangelismos" Athens Greece
    22 General Hospital of Athens "Gennimatas" Athens Greece
    23 General Hospital of Athens "Laiko" Athens Greece
    24 General Hospital of Athens "Ippokratio" Thessaloníki Greece
    25 Military Health Center, Division of Endocrinology Budapest Hungary
    26 Semmelweis University Faculty of Medicine Budapest Hungary
    27 University of Pécs Medical School Pécs Hungary
    28 Universita Vita-Salute San Raffaele Milano Italy 20132
    29 Azienda Ospedaliera Universitaria Federico II Napoli Italy
    30 Waitemata District Health Board, North Shore Hospital Takapuna New Zealand
    31 Endocrine, Diabetes and Research Centre, Wellington Hospital Wellington New Zealand
    32 Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow Krakow Poland
    33 Centrum Nowoczesnch Terapii "Dobry Lekarz" Kraków Poland 31-011
    34 The Centre of Postgraduate Medical Education Warsaw Poland
    35 National Institute of Endocrinology "C. I. Parhon" Bucharest Romania
    36 Emergency Clinical County Hospital, Endocrinology Clinic Cluj-Napoca Romania
    37 Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases Belgrade Serbia
    38 Clinical Centre of Vojvodina, Clinic for Endocrinology, Diabetes and Metabolic Diseases Novi Sad Serbia
    39 University Hospital Bratislava Bratislava Slovakia
    40 National Institute of Endocrinology and Diabetology Ľubochňa Slovakia
    41 University Hospitals Coventry and Warwickshire NHS Trust Coventry United Kingdom
    42 Leeds Teaching Hospitals NHS Trust Leeds United Kingdom LS9 7TF
    43 Barts and the London School of Medicine London United Kingdom
    44 The Christie NHS Foundation Trust Manchester United Kingdom
    45 Salford Royal NHS Foundation Trust Salford United Kingdom

    Sponsors and Collaborators

    • Crinetics Pharmaceuticals Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Crinetics Pharmaceuticals Inc.
    ClinicalTrials.gov Identifier:
    NCT03789656
    Other Study ID Numbers:
    • CRN00808-03
    • 2018-002230-20
    First Posted:
    Dec 28, 2018
    Last Update Posted:
    Jul 29, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Crinetics Pharmaceuticals Inc.
    Acromegaly
    ACROBAT
    EDGE
    Paltusotine
    Additional relevant MeSH terms:
    Acromegaly

    Study Results

    No Results Posted as of Jul 29, 2021