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A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)

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: NCT04261712
Recruitment Status : Enrolling by invitation
First Posted : February 10, 2020
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Paltusotine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Long-term Extension Study to Evaluate the Safety and Efficacy of CRN00808 in Subjects With Acromegaly (ACROBAT Advance)
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paltusotine Drug: Paltusotine
Paltusotine, capsules, once daily by mouth
Other Name: CRN00808




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) throughout the study [ Time Frame: Week 56 ]

Secondary Outcome Measures :
  1. Change in insulin-like growth factor-1 (IGF-1) level [ Time Frame: Week 16, Week 52 ]
  2. Change in growth hormone (GH) level [ Time Frame: Week 16, Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Completed one of the parent studies (Acrobat Evolve [CRN00808-02] or Acrobat Edge [CRN00808-03])
  2. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
  3. Willing to provide signed informed consent

Exclusion Criteria:

  1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
  2. Pituitary radiation since completing participation in parent studies
  3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
  4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
  5. History of alcohol or substance abuse in the past 12 months
  6. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
  7. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
  8. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
  9. Subjects with symptomatic cholelithiasis
  10. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261712


Locations
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Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.
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Responsible Party: Crinetics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04261712    
Other Study ID Numbers: CRN00808-05
U1111-1245-5276 ( Other Identifier: WHO )
2019-002193-31 ( EudraCT Number )
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
ADVANCE
Paltusotine
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases