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

NCT03789656 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CRN00808-032018-002230-20
• Study Type: interventional
• Target: 47
• Locations: 12 countries
• Sites: 26

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

Keywords

Acromegaly; ACROBAT; EDGE; Paltusotine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level

  Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).

  13 Weeks

Secondary Outcomes (2)

• Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)

  13 Weeks

• Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN

  13 Weeks

Study Arms (1)

Paltusotine

EXPERIMENTAL

Drug: Paltusotine

Interventions

Paltusotine DRUG

Paltusotine, capsules, once daily by mouth

Also known as: CRN00808

Paltusotine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18 to 75 years of age
• Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
• Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
• Willing to provide signed informed consent

You may not qualify if:

• Treatment naïve acromegaly subjects
• Prior treatment with paltusotine
• Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
• History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
• Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
• 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
• History of alcohol or substance abuse in the past 12 months
• Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
• Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
• Subjects with symptomatic cholelithiasis
• 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
• 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
• Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (26)

UCLA Gonda Diabetes Center

Los Angeles, California, 90095, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

OHSU Northwest Pituitary Center

Portland, Oregon, 97239, United States

Location

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, Brazil

Location

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

Rio de Janeiro, Brazil

Location

CPQuali Pesquisa Clinica

São Paulo, Brazil

Location

LMU Clinic of University of Munich

Munich, Germany

Location

General Hospital of Athens "Evangelismos"

Athens, Greece

Location

General Hospital of Athens "Gennimatas"

Athens, Greece

Location

General Hospital of Athens "Laiko"

Athens, Greece

Location

General Hospital of Athens "Ippokratio"

Thessaloniki, Greece

Location

Military Health Center, Division of Endocrinology

Budapest, Hungary

Location

Semmelweis University Faculty of Medicine

Budapest, Hungary

Location

University of Pécs Medical School

Pécs, Hungary

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

Location

Waitemata District Health Board, North Shore Hospital

Takapuna, New Zealand

Location

Endocrine, Diabetes and Research Centre, Wellington Hospital

Wellington, New Zealand

Location

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

Krakow, Poland

Location

National Institute of Endocrinology "C. I. Parhon"

Bucharest, Romania

Location

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

Belgrade, Serbia

Location

University Hospital Bratislava

Bratislava, Slovakia

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36792844 DERIVED

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Crinetics Clinical Trials
• Organization: Crinetics Pharmaceuticals, Inc

clinicaltrials@crinetics.com

+1 858-450-6464

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: March 12, 2019
• Primary Completion: August 3, 2020
• Study Completion: August 31, 2020
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); GB (2); BR (3); RO (1); SE (1); SL (1); HU (3); DE (1); GR (4); US (6); PL (1); IT (1)