A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)
Primary Purpose
Acromegaly
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Paltusotine
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, ACROBAT, ADVANCE, Paltusotine
Eligibility Criteria
Inclusion Criteria:
- Completed one of the parent studies (Acrobat Evolve [CRN00808-02] or Acrobat Edge [CRN00808-03])
- 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:
- Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
- Pituitary radiation since completing participation in parent studies
- History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
- Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
- History of alcohol or substance abuse in the past 12 months
- Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
- 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
Sites / Locations
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Hippokration General hospital of Thessaloniki
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
- Crinetics Study Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paltusotine
Arm Description
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Secondary Outcome Measures
Change in insulin-like growth factor-1 (IGF-1) level
Change in growth hormone (GH) level
Full Information
NCT ID
NCT04261712
First Posted
February 6, 2020
Last Updated
October 5, 2022
Sponsor
Crinetics Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04261712
Brief Title
A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)
Official Title
An Open Label, Long-term Extension Study to Evaluate the Safety and Efficacy of CRN00808 in Subjects With Acromegaly (ACROBAT Advance)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
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
A phase 2, open label, long-term extension study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, ACROBAT, ADVANCE, 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
43 (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, once daily by mouth
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Time Frame
Week 56
Secondary Outcome Measure Information:
Title
Change in insulin-like growth factor-1 (IGF-1) level
Time Frame
Week 16, Week 52
Title
Change in growth hormone (GH) level
Time Frame
Week 16, Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completed one of the parent studies (Acrobat Evolve [CRN00808-02] or Acrobat Edge [CRN00808-03])
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:
Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
Pituitary radiation since completing participation in parent studies
History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
History of alcohol or substance abuse in the past 12 months
Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
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
Facility Information:
Facility Name
Crinetics Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Crinetics Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Crinetics Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Crinetics Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Crinetics Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Crinetics Study Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Crinetics Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Crinetics Study Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Crinetics Study Site
City
Rio De Janeiro
ZIP/Postal Code
21941
Country
Brazil
Facility Name
Crinetics Study Site
City
São Paulo
ZIP/Postal Code
01228
Country
Brazil
Facility Name
Crinetics Study Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Crinetics Study Site
City
Athens
Country
Greece
Facility Name
Hippokration General hospital of Thessaloniki
City
Thessaloníki
Country
Greece
Facility Name
Crinetics Study Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Crinetics Study Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Crinetics Study Site
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Crinetics Study Site
City
Belgrade
Country
Serbia
Facility Name
Crinetics Study Site
City
Coventry
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)
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