Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789656
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE December 27, 2018
First Posted Date  ICMJE December 28, 2018
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE January 15, 2019
Actual Primary Completion Date August 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level [ Time Frame: 13 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
Change from baseline (mean of Screening values) in IGF-1 level [ Time Frame: 13 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
  • Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN) [ Time Frame: 13 Weeks ]
  • Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN [ Time Frame: 13 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • Proportion of subjects with the mean of their last two consecutive IGF-1 measurements ≤ULN [ Time Frame: 13 Weeks ]
  • Proportion of subjects with the mean of their last two consecutive IGF-1 measurements ≤1.5×ULN [ Time Frame: 13 Weeks ]
  • Proportion of subjects who achieve serum GH <5.0 ng/mL [ Time Frame: 13 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acromegaly
Intervention  ICMJE Drug: Paltusotine
Paltusotine, capsules, once daily by mouth
Other Name: CRN00808
Study Arms  ICMJE Experimental: Paltusotine
Intervention: Drug: Paltusotine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
47
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2018)
45
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date August 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Germany,   Greece,   Hungary,   Italy,   New Zealand,   Poland,   Romania,   Serbia,   Slovakia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03789656
Other Study ID Numbers  ICMJE CRN00808-03
2018-002230-20 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Crinetics Pharmaceuticals Inc.
Study Sponsor  ICMJE Crinetics Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Crinetics Pharmaceuticals Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP