search
Back to results

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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Paltusotine
Sponsored by
Crinetics Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, ACROBAT, EDGE, Paltusotine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Keck Medical Center of USC University of Southern California
  • UCLA Gonda Diabetes Center
  • Northwestern University Feinberg School of Medicine
  • Johns Hopkins University
  • Massachusetts General Hospital
  • University of Michigan
  • Cleveland Clinic
  • Ohio State University
  • OHSU Northwest Pituitary Center
  • Allegheny Endocrinology Associates
  • Research Institute of Dallas
  • Royal Adelaide Hospital
  • Royal Brisbane & Women's Hospital
  • Royal Melbourne Hospital
  • Keogh Institute for Medical Research
  • CETI - Centro de Estudos em Terapias Inovadoras
  • Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
  • CPQuali Pesquisa Clinica
  • LMU Clinic of University of Munich
  • MEDICOVER Neuroendokrinologie
  • General Hospital of Athens "Evangelismos"
  • General Hospital of Athens "Gennimatas"
  • General Hospital of Athens "Laiko"
  • General Hospital of Athens "Ippokratio"
  • Military Health Center, Division of Endocrinology
  • Semmelweis University Faculty of Medicine
  • University of Pécs Medical School
  • Universita Vita-Salute San Raffaele
  • Azienda Ospedaliera Universitaria Federico II
  • Waitemata District Health Board, North Shore Hospital
  • Endocrine, Diabetes and Research Centre, Wellington Hospital
  • Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
  • Centrum Nowoczesnch Terapii "Dobry Lekarz"
  • The Centre of Postgraduate Medical Education
  • National Institute of Endocrinology "C. I. Parhon"
  • Emergency Clinical County Hospital, Endocrinology Clinic
  • Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
  • Clinical Centre of Vojvodina, Clinic for Endocrinology, Diabetes and Metabolic Diseases
  • University Hospital Bratislava
  • National Institute of Endocrinology and Diabetology
  • University Hospitals Coventry and Warwickshire NHS Trust
  • Leeds Teaching Hospitals NHS Trust
  • Barts and the London School of Medicine
  • The Christie NHS Foundation Trust
  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paltusotine

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level

Secondary Outcome Measures

Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN)
Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN

Full Information

First Posted
December 27, 2018
Last Updated
July 27, 2021
Sponsor
Crinetics Pharmaceuticals Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03789656
Brief Title
An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crinetics Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, ACROBAT, EDGE, Paltusotine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paltusotine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paltusotine
Other Intervention Name(s)
CRN00808
Intervention Description
Paltusotine, capsules, once daily by mouth
Primary Outcome Measure Information:
Title
Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level
Time Frame
13 Weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN)
Time Frame
13 Weeks
Title
Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN
Time Frame
13 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Keck Medical Center of USC University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Gonda Diabetes Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OHSU Northwest Pituitary Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Allegheny Endocrinology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
Country
Australia
Facility Name
Keogh Institute for Medical Research
City
Nedlands
Country
Australia
Facility Name
CETI - Centro de Estudos em Terapias Inovadoras
City
Curitiba
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
City
Rio De Janeiro
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica
City
São Paulo
Country
Brazil
Facility Name
LMU Clinic of University of Munich
City
Munich
Country
Germany
Facility Name
MEDICOVER Neuroendokrinologie
City
München
Country
Germany
Facility Name
General Hospital of Athens "Evangelismos"
City
Athens
Country
Greece
Facility Name
General Hospital of Athens "Gennimatas"
City
Athens
Country
Greece
Facility Name
General Hospital of Athens "Laiko"
City
Athens
Country
Greece
Facility Name
General Hospital of Athens "Ippokratio"
City
Thessaloníki
Country
Greece
Facility Name
Military Health Center, Division of Endocrinology
City
Budapest
Country
Hungary
Facility Name
Semmelweis University Faculty of Medicine
City
Budapest
Country
Hungary
Facility Name
University of Pécs Medical School
City
Pécs
Country
Hungary
Facility Name
Universita Vita-Salute San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
Country
Italy
Facility Name
Waitemata District Health Board, North Shore Hospital
City
Takapuna
Country
New Zealand
Facility Name
Endocrine, Diabetes and Research Centre, Wellington Hospital
City
Wellington
Country
New Zealand
Facility Name
Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
City
Krakow
Country
Poland
Facility Name
Centrum Nowoczesnch Terapii "Dobry Lekarz"
City
Kraków
ZIP/Postal Code
31-011
Country
Poland
Facility Name
The Centre of Postgraduate Medical Education
City
Warsaw
Country
Poland
Facility Name
National Institute of Endocrinology "C. I. Parhon"
City
Bucharest
Country
Romania
Facility Name
Emergency Clinical County Hospital, Endocrinology Clinic
City
Cluj-Napoca
Country
Romania
Facility Name
Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
City
Belgrade
Country
Serbia
Facility Name
Clinical Centre of Vojvodina, Clinic for Endocrinology, Diabetes and Metabolic Diseases
City
Novi Sad
Country
Serbia
Facility Name
University Hospital Bratislava
City
Bratislava
Country
Slovakia
Facility Name
National Institute of Endocrinology and Diabetology
City
Ľubochňa
Country
Slovakia
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust
City
Coventry
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Barts and the London School of Medicine
City
London
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs