A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)

May 13, 2026 updated by: Crinetics Pharmaceuticals Inc.

An Open Label, Long-term Extension Study to Evaluate the Safety and Efficacy of CRN00808 in Subjects With Acromegaly (ACROBAT Advance)

A phase 2, open label, long-term extension 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 acromegaly.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

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

  • Brazil
      • Rio de Janeiro, Brazil, 20231
        • Crinetics Study Site
      • Rio de Janeiro, Brazil, 21941
        • Crinetics Study Site
      • São Paulo, Brazil, 01228
        • Crinetics Study Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Crinetics Study Site
  • Germany
      • München, Germany, 80336
        • Crinetics Study Site
  • Greece
      • Athens, Greece, 10676
        • Crinetics Study Site
      • Athens, Greece, 11527
        • Crinetics Study Site 1
      • Athens, Greece, 11527
        • Crinetics Study Site 2
      • 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
  • Serbia
      • Belgrade, Serbia, 11000
        • Crinetics Study Site
  • United Kingdom
      • Coventry, United Kingdom
        • Crinetics Study Site
      • Leeds, United Kingdom, LS97TF
        • Crinetics Study Site
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Crinetics Study Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Crinetics Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Crinetics Study Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Crinetics Study Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Crinetics Study Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Crinetics Study Site
    • Texas
      • Dallas, Texas, United States, 75231
        • 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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Completed one of the parent studies (Acrobat Evolve [CRN00808-02] or Acrobat Edge [CRN00808-03])
  2. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
  3. Willing to provide signed informed consent

Exclusion Criteria:

  1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
  2. Pituitary radiation since completing participation in parent studies
  3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
  4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
  5. History of alcohol or substance abuse in the past 12 months
  6. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
  7. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
  8. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
  9. Subjects with symptomatic cholelithiasis
  10. Subjects with clinically significant abnormal findings during the Screening Period, and 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Time Frame: Week 316
Week 316

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in insulin-like growth factor-1 (IGF-1) level
Time Frame: Week 16, Week 312
Week 16, Week 312
Change in growth hormone (GH) level
Time Frame: Week 16, Week 312
Week 16, Week 312

Collaborators and Investigators

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

Sponsor

Crinetics Pharmaceuticals Inc.

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)

January 29, 2020

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 10, 2020

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

  • CRN00808-05
  • U1111-1245-5276 (Other Identifier: WHO)
  • 2019-002193-31 (EudraCT Number)
  • 2024-511921-75-00 (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

product manufactured in and exported from the U.S.

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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