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

May 13, 2026 updated by: Crinetics Pharmaceuticals Inc.

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

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
      • Buenos Aires, Argentina, C1405BCH
        • Crinetics Study Site
      • CABA, Argentina, 1425
        • Crinetics Study Site
      • CABA, Argentina, C1199ABB
        • Crinetics Study Site
      • Córdoba, Argentina, X5000
        • Crinetics Study Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1012AAR
        • Crinetics Study Site
  • Brazil
      • Rio de Janeiro, Brazil, 20231-092
        • Crinetics Study Site
      • São Paulo, Brazil, 05403-000
        • Crinetics Study Site
      • São Paulo, Brazil, 1228000
        • Crinetics Study Site
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-275
        • Crinetics Study Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130100
        • Crinetics Study Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Crinetics Study Site
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Crinetics Study Site
      • Campinas, São Paulo, Brazil, 13060-904
        • Crinetics Study Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Crinetics Study Site
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Crinetics Study Site (b)
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Crinetics Study Site
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Crinetics Study Site
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Crinetics Study Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Crinetics Study Site
    • Hunan
      • Changsha, Hunan, China, 410003
        • Crinetics Study Site
    • Shandong
      • Jinan, Shandong, China, 250063
        • Crinetics Study Site
    • Shanxi
      • Xi’an, Shanxi, China, 710032
        • Crinetics Study Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Crinetics Study Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Crinetics Study Site
  • France
      • Marseille, France, 13395
        • Crinetics Study Site
      • Pessac, France, 33604
        • Crinetics Study Site
      • Toulouse, France, 31400
        • Crinetics Study Site
  • Germany
      • Aachen, Germany, 52074
        • Crinetics Study Site
      • Berlin, Germany, 10117
        • Crinetics Study Site
      • München, Germany, 80336
        • Crinetics Study Site
      • München, Germany, 81667
        • Crinetics Study Site
      • Würzburg, Germany, 97080
        • Crinetics Study Site
  • Greece
      • Athens, Greece, 10676
        • Crinetics Study Site
      • Athens, Greece, 11527
        • Crinetics Study Site (b)
      • Thessaloniki, Greece, 54642
        • Crinetics Study Site
  • Hungary
      • Budapest, Hungary, 1083
        • Crinetics Study Site
      • Budapest, Hungary, 1062
        • Crinetics Study Site
      • Pécs, Hungary, 7624
        • Crinetics Study Site
  • India
      • Chandigarh, India, 160012
        • Crinetics Study Site
      • Delhi, India, 110029
        • Crinetics Study Site
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Crinetics Study Site
      • Belagavi, Karnataka, India, 590010
        • Crinetics Study Site
    • Kerala
      • Kochi, Kerala, India, 682041
        • Crinetics Study Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Crinetics Study Site
  • Israel
      • Petah Tikva, Israel, 4941492
        • Crinetics Study Site
  • Italy
      • Roma, Italy, 00168
        • Crinetics Study Site
  • Poland
      • Bydgoszcz, Poland, 85-605
        • Crinetics Study Site
      • Poznan, Poland, 60-355
        • Crinetics Study Site
      • Wroclaw, Poland, 50-367
        • Crinetics Study Site
  • Spain
      • Barcelona, Spain, 08035
        • Crinetics Study Site
  • United Kingdom
      • London, United Kingdom, EC1M 6BQ
        • Crinetics Study Site
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Crinetics Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Crinetics Study Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Crinetics Study Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Crinetics Study Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Crinetics Study Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • 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

18 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 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)

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
Measure Description
Time Frame
Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR)
Time Frame: Week 24
A value >1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IGF-1 From Baseline to EOT
Time Frame: Baseline to 24 weeks
A value >1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Baseline was defined as the last non-missing assessment prior to first dose of study drug for all assessments except IGF-1, growth hormone (GH), and acromegaly symptoms diary (ASD). Change from Baseline was determined by calculating (post-Baseline value - Baseline value).
Baseline to 24 weeks
Percentage of Participants Achieving IGF-1 <1.3×ULN at EOR
Time Frame: 24 weeks
A value >1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level <1.3×ULN based on the average of last 2 measurements.
24 weeks
Percentage of Participants With Growth Hormone (GH) Concentration <1 ng/mL at Week 22
Time Frame: Week 22
The average from integrated GH sampling at week 22 was used to determine response.
Week 22
Change From Baseline in Total Acromegaly Symptoms Diary (ASD) Score to EOT
Time Frame: Baseline to 24 weeks
The ASD is a sponsor-developed daily diary to assess important acromegaly symptoms from the patient perspective. The weekly average ASD total score is calculated from 7 items associated with acromegaly (headache pain, joint pain, sweating, fatigue, weakness in legs, swelling, and numbness or tingling). The ASD total score ranges from 0 to 70 with each symptom contributing up to 10 points. A higher score = higher symptom severity. Change from baseline in total ASD was defined as the postbaseline total ASD score (the average of the available scores seven days on or prior to the scheduled visit date) minus the baseline total ASD score.
Baseline to 24 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)

December 17, 2021

Primary Completion (Actual)

January 20, 2024

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRN00808-08
  • 2021-001703-32 (EudraCT Number)
  • 2024-511924-15-00 (Ctis)

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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