An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

NCT ID: NCT03789656

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2020-08-31

Brief Summary

An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paltusotine

Group Type: EXPERIMENTAL

Paltusotine

Intervention Type: DRUG

Paltusotine, capsules, once daily by mouth

Interventions

Paltusotine

Paltusotine, capsules, once daily by mouth

Intervention Type: DRUG

Other Intervention Names

CRN00808

Eligibility Criteria

Inclusion Criteria

1. Male and female subjects 18 to 75 years of age

2. Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens

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. Treatment naïve acromegaly subjects

2. Prior treatment with paltusotine

3. Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.

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. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result

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, 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

12. Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg

13. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Crinetics Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Semmelweis University Faculty of Medicine

Budapest, , Hungary

University of Pécs Medical School

Pécs, , Hungary

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Waitemata District Health Board, North Shore Hospital

Takapuna, , New Zealand

UCLA Gonda Diabetes Center

Los Angeles, California, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

OHSU Northwest Pituitary Center

Portland, Oregon, United States

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, United States

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, , Brazil

Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia

Rio de Janeiro, , Brazil

CPQuali Pesquisa Clinica

São Paulo, , Brazil

LMU Clinic of University of Munich

Munich, , Germany

General Hospital of Athens "Evangelismos"

Athens, , Greece

General Hospital of Athens "Gennimatas"

Athens, , Greece

General Hospital of Athens "Laiko"

Athens, , Greece

General Hospital of Athens "Ippokratio"

Thessaloniki, , Greece

Military Health Center, Division of Endocrinology

Budapest, , Hungary

Endocrine, Diabetes and Research Centre, Wellington Hospital

Wellington, , New Zealand

Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow

Krakow, , Poland

National Institute of Endocrinology "C. I. Parhon"

Bucharest, , Romania

Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases

Belgrade, , Serbia

University Hospital Bratislava

Bratislava, , Slovakia

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, , United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Countries

United States; Brazil; Germany; Greece; Hungary; Italy; New Zealand; Poland; Romania; Serbia; Slovakia; United Kingdom

References

Martin S, Bender RH, Krasner A, Marmon T, Monahan M, Nelson L. Development and evaluation of the Acromegaly Symptom Diary. J Patient Rep Outcomes. 2023 Feb 15;7(1):15. doi: 10.1186/s41687-023-00541-7.

Reference Type: DERIVED

PMID: 36792844 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-002230-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRN00808-03

Identifier Type: -

Identifier Source: org_study_id