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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. Read our disclaimer for details. Identifier: NCT04837040
Recruitment Status : Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : November 14, 2022
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.

Brief Summary:
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 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 : July 2023
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

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

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, in units of ULN, 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: 34 Weeks ]
  3. Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR [ Time Frame: 36 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Male and female subjects ≥18 years of age
  2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×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 or treatment-withdrawn 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 (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)

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 identifier (NCT number): NCT04837040

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United States, Arizona
Crinetics Study Site
Phoenix, Arizona, United States, 85013
United States, California
Crinetics Study Site
Los Angeles, California, United States, 90048
Crinetics Study Site
Torrance, California, United States, 90502
United States, Colorado
Crinetics Study Site
Aurora, Colorado, United States, 80045
United States, Florida
Crinetics Study Site
Miami, Florida, United States, 33136
United States, Maryland
Crinetics Study Site
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Crinetics Study Site
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Crinetics Study Site
Philadelphia, Pennsylvania, United States, 19104
Crinetics Study Site
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Crinetics Study Site
Nashville, Tennessee, United States, 37203
Crinetics Study Site
Caba, Buenos Aires, Argentina, C1012AAR
Crinetics Study Site
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1405BCH
Crinetics Study Site
Córdoba, Argentina, X5000
Crinetics Study Site
Gent, Belgium, 9000
Crinetics Study Site
Fortaleza, Ceará, Brazil, 60430-275
Crinetics Study Site
Curitiba, Paraná, Brazil, 80030-110
Crinetics Study Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90410-000
Crinetics Study Site
Ribeirão Preto, São Paulo, Brazil, 14051-140
Crinetics Study Site
Rio De Janeiro, Brazil, 21941-913
Crinetics Study Site
São Paulo, Brazil, 01228000
Crinetics Study Site
São Paulo, Brazil, 05453-000
Crinetics Study Site
Sofia, Bulgaria, 1431
Crinetics Study Site
Bron, France, 69677
Crinetics Study Site
Pessac, France, 33604
Crinetics Study Site
Budapest, Hungary, 1083
Crinetics Study Site
Pécs, Hungary, 7624
Crinetics Study Site
Be'er Sheva, Israel, 8410101
Crinetics Study Site
Petach Tikva, Israel, 4941480
Crinetics Study Site
Tel Aviv, Israel, 6423906
Crinetics Study Site
Pisa, Italy, 56124
Crinetics Study Site
Roma, Italy, 00168
Crinetics Study Site
San Isidro, Lima, Peru, 15023
Crinetics Study Site
Bydgoszcz, Poland, 85-605
Crinetics Study Site
Poznań, Poland, 60-355
Crinetics Study Site
Wrocław, Poland, 50-367
Russian Federation
Crinetics Study Site
Kemerovo, Kemerovo Oblast, Russian Federation, 650066
Crinetics Study Site
Novosibirsk, Novosibirsk Oblast, Russian Federation, 630005
Crinetics Study Site
Novosibirsk, Novosibirsk Oblast, Russian Federation, 630087
Crinetics Study Site
Kazan, Republic Of Tatarstan, Russian Federation, 420097
Crinetics Study Site
Samara, Samara Oblast, Russian Federation, 443041
Crinetics Study Site
Moscow, Russian Federation, 117186
Crinetics Study Site
Moscow, Russian Federation, 125008
Crinetics Study Site
Belgrade, Serbia, 11000
United Kingdom
Crinetics Study Site
Sheffield, South Yorkshire, United Kingdom, S102JF
Crinetics Study Site
Coventry, West Midlands, United Kingdom, CV2 2DX
Crinetics Study Site
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.
Additional Information:
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Responsible Party: Crinetics Pharmaceuticals Inc. Identifier: NCT04837040    
Other Study ID Numbers: CRN00808-09
2020-005431-70 ( EudraCT Number )
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 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.:
Additional relevant MeSH terms:
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Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases