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A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-1)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837040
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.

Study Description
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Brief Summary:
A randomized, placebo-controlled 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 previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Paltusotine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Paltusotine Drug: Paltusotine
Paltusotine, tablets, once daily by mouth
Other Name: CRN00808
Placebo Comparator: Placebo Drug: Placebo
Placebo, tablets, once daily by mouth


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who maintain biochemical response in IGF-1 (≤1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR) [ Time Frame: 36 Weeks ]

Secondary Outcome Measures :
  1. Change from baseline in IGF-1 to EOR [ Time Frame: 36 Weeks ]
  2. Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at baseline [ Time Frame: 36 Weeks ]
  3. Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR [ Time Frame: 36 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects ≥18 years of age
  2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 <ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
  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 24 weeks prior to Screening or history of pituitary radiation therapy
  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. Known history of HIV, hepatitis B, or active hepatitis C
  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, or 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 currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists, or short acting somatostatin analogs (with 12 weeks prior to Screening)
Contacts and Locations
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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): NCT04837040


Contacts
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Contact: Crinetics Clinical Trials 833-827-9741 clinicaltrials@crinetics.com

Locations
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Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.
More Information
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Additional Information:

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Responsible Party: Crinetics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04837040    
Other Study ID Numbers: CRN00808-09
2020-005431-70 ( EudraCT Number )
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
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
PATHFNDR
Paltusotine
CRN00808
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