A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)

Brief Title

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)

Official Title

A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)

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 non-pharmacologically treated acromegaly.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Proportion of subjects who achieve 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 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

76

Start Date

December 17, 2021

Completion Date

August 2025

Primary Completion Date

August 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Male and female subjects ≥18 years of age

          2. Confirmed diagnosis of acromegaly and either medically naïve, not currently treated,
             or willing to washout during the study screening period.

          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. Pituitary radiation therapy within 3 years of Screening

          2. Prior treatment with paltusotine

          3. History of ineffective or intolerance to octreotide or lanreotide

          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 or previously using pegvisomant or cabergoline (within 16 weeks
             prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 833-827-9741, [email protected]

Location Countries

Argentina

Location Countries

Argentina

NCT ID

NCT05192382

Organization ID

CRN00808-08

Secondary IDs

2021-001703-32

Responsible Party

Sponsor

Study Sponsor

Crinetics Pharmaceuticals Inc.

Study Sponsor

, , 

Verification Date

March 2023