A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

Brief Title

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

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)

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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)

Secondary Outcome

 Change from baseline in IGF-1, in units of ULN, to EOR

Condition

Acromegaly

Intervention

Paltusotine

Study Arms / Comparison Groups

 Paltusotine

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

58

Start Date

May 12, 2021

Completion Date

June 2025

Primary Completion Date

July 2023

Eligibility Criteria

        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 Treatment naïve or treatment-withdrawn acromegaly subjects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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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Location Countries

Argentina

Location Countries

Argentina

NCT ID

NCT04837040

Organization ID

CRN00808-09

Secondary IDs

2020-005431-70

Responsible Party

Sponsor

Study Sponsor

Crinetics Pharmaceuticals Inc.

Study Sponsor

, , 

Verification Date

November 2022