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

July 27, 2021 updated by: Crinetics Pharmaceuticals Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Herston, Australia
        • Royal Brisbane & Women's Hospital
      • Melbourne, Australia
        • Royal Melbourne Hospital
      • Nedlands, Australia
        • Keogh Institute for Medical Research
  • Brazil
      • Curitiba, Brazil
        • Ceti - Centro de Estudos Em Terapias Inovadoras
      • Rio De Janeiro, Brazil
        • Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
      • São Paulo, Brazil
        • CPQuali Pesquisa Clínica
  • Germany
      • Munich, Germany
        • LMU Clinic of University of Munich
      • München, Germany
        • Medicover Neuroendokrinologie
  • Greece
      • Athens, Greece
        • General Hospital of Athens "Evangelismos"
      • Athens, Greece
        • General Hospital of Athens "Gennimatas"
      • Athens, Greece
        • General Hospital of Athens "LAIKO"
      • Thessaloníki, Greece
        • General Hospital of Athens "Ippokratio"
  • Hungary
      • Budapest, Hungary
        • Semmelweis University Faculty of Medicine
      • Budapest, Hungary
        • Military Health Center, Division of Endocrinology
      • Pécs, Hungary
        • University of Pecs Medical School
  • Italy
      • Milano, Italy, 20132
        • Università Vita-Salute San Raffaele
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria Federico II
  • New Zealand
      • Takapuna, New Zealand
        • Waitemata District Health Board, North Shore Hospital
      • Wellington, New Zealand
        • Endocrine, Diabetes and Research Centre, Wellington Hospital
  • Poland
      • Krakow, Poland
        • Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
      • Kraków, Poland, 31-011
        • Centrum Nowoczesnch Terapii "Dobry Lekarz"
      • Warsaw, Poland
        • The Centre of Postgraduate Medical Education
  • Romania
      • Bucharest, Romania
        • National Institute of Endocrinology "C. I. Parhon"
      • Cluj-Napoca, Romania
        • Emergency Clinical County Hospital, Endocrinology Clinic
  • Serbia
      • Belgrade, Serbia
        • Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases
      • Novi Sad, Serbia
        • Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases
  • Slovakia
      • Bratislava, Slovakia
        • University Hospital Bratislava
      • Ľubochňa, Slovakia
        • National Institute of Endocrinology and Diabetology
  • United Kingdom
      • Coventry, United Kingdom
        • University Hospitals Coventry and Warwickshire NHS Trust
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust
      • London, United Kingdom
        • Barts and the London School of Medicine
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Salford, United Kingdom
        • Salford Royal NHS Foundation Trust
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC University of Southern California
      • Los Angeles, California, United States, 90095
        • UCLA Gonda Diabetes Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Northwest Pituitary Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Endocrinology Associates
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Institute Of Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paltusotine
Drug: Paltusotine
Paltusotine, capsules, once daily by mouth
Other Names:
  • CRN00808

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level
Time Frame: 13 Weeks
13 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN)
Time Frame: 13 Weeks
13 Weeks
Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN
Time Frame: 13 Weeks
13 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Crinetics Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

August 3, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

December 27, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRN00808-03
  • 2018-002230-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acromegaly

Clinical Trials on Paltusotine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe