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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-29

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acromegaly

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Acromegaly ACROBAT ADVANCE Paltusotine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Paltusotine

Group Type EXPERIMENTAL

Paltusotine

Intervention Type DRUG

Paltusotine, once daily by mouth

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paltusotine

Paltusotine, once daily by mouth

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CRN00808

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Review the countries where the study has at least one active or historical site.

Romania Slovakia United States Brazil Greece Hungary Serbia United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1245-5276

Identifier Type: OTHER

Identifier Source: secondary_id

2019-002193-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-511921-75-00

Identifier Type: CTIS

Identifier Source: secondary_id

CRN00808-05

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Paltusotine

Paltusotine

Interventions

Paltusotine

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Crinetics Pharmaceuticals Inc.

Responsible Party

Locations

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site 1

Crinetics Study Site 2

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Crinetics Study Site

Countries

Other Identifiers

U1111-1245-5276

2019-002193-31

2024-511921-75-00

CRN00808-05