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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04261712

Enrollment

Registered

2020-02-10

Start date

2020-01-29

Completion date

2026-06-30

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

Acromegaly, ACROBAT, ADVANCE, Paltusotine

Brief summary

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.

Interventions

DRUGPaltusotine

Paltusotine, once daily by mouth

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil, Germany, Greece, Hungary, Serbia, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026