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

March 28, 2024 updated by: Crinetics Pharmaceuticals Inc.

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5000
        • Crinetics Study Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1012AAR
        • Crinetics Study Site
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1405BCH
        • Crinetics Study Site
  • Belgium
      • Gent, Belgium, 9000
        • Crinetics Study Site
  • Brazil
      • Rio De Janeiro, Brazil, 21941-913
        • Crinetics Study Site
      • São Paulo, Brazil, 01228000
        • Crinetics Study Site
      • São Paulo, Brazil, 05453-000
        • Crinetics Study Site
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-275
        • Crinetics Study Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Crinetics Study Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90410-000
        • Crinetics Study Site
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Crinetics Study Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Crinetics Study Site
  • France
      • Bron, France, 69677
        • Crinetics Study Site
      • Pessac, France, 33604
        • Crinetics Study Site
  • Hungary
      • Budapest, Hungary, 1083
        • Crinetics Study Site
      • Pécs, Hungary, 7624
        • Crinetics Study Site
  • Israel
      • Be'er Sheva, Israel, 8410101
        • Crinetics Study Site
      • Petach Tikva, Israel, 4941480
        • Crinetics Study Site
      • Tel Aviv, Israel, 6423906
        • Crinetics Study Site
  • Italy
      • Roma, Italy, 00168
        • Crinetics Study Site
  • Peru
    • Lima
      • San Isidro, Lima, Peru, 15023
        • Crinetics Study Site
  • Poland
      • Bydgoszcz, Poland, 85-605
        • Crinetics Study Site
      • Poznań, Poland, 60-355
        • Crinetics Study Site
      • Wrocław, Poland, 50-367
        • Crinetics Study Site
  • Russian Federation
      • Moscow, Russian Federation, 117186
        • Crinetics Study Site
      • Moscow, Russian Federation, 125008
        • Crinetics Study Site
    • Kemerovo Oblast
      • Kemerovo, Kemerovo Oblast, Russian Federation, 650066
        • Crinetics Study Site
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russian Federation, 630005
        • Crinetics Study Site
      • Novosibirsk, Novosibirsk Oblast, Russian Federation, 630087
        • Crinetics Study Site
    • Republic Of Tatarstan
      • Kazan, Republic Of Tatarstan, Russian Federation, 420097
        • Crinetics Study Site
    • Samara Oblast
      • Samara, Samara Oblast, Russian Federation, 443041
        • Crinetics Study Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Crinetics Study Site
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Crinetics Study Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S102JF
        • Crinetics Study Site
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV2 2DX
        • Crinetics Study Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Crinetics Study Site
    • California
      • Los Angeles, California, United States, 90048
        • Crinetics Study Site
      • Torrance, California, United States, 90502
        • Crinetics Study Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Crinetics Study Site
    • Florida
      • Miami, Florida, United States, 33136
        • Crinetics Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Crinetics Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Crinetics Study Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Crinetics Study Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Crinetics Study Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Crinetics Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo, tablets, once daily by mouth
Experimental: Paltusotine
Drug: Paltusotine
Paltusotine, tablets, once daily by mouth
Other Names:
  • CRN00808

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
36 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in IGF-1, in units of ULN, to EOR
Time Frame: 36 Weeks
36 Weeks
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
34 Weeks
Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR
Time Frame: 36 Weeks
36 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Crinetics Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Actual)

July 10, 2023

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRN00808-09
  • 2020-005431-70 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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