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

An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge)

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.

Study Overview

• Status: Completed
• Conditions: Acromegaly
• Intervention / Treatment: Drug: Paltusotine

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Curitiba, Brazil
    • Ceti - Centro de Estudos Em Terapias Inovadoras
  • Rio De Janeiro, Brazil
    • Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
  • São Paulo, Brazil
    • CPQuali Pesquisa Clínica
• Germany
  • Munich, Germany
    • LMU Clinic of University of Munich
• Greece
  • Athens, Greece
    • General Hospital of Athens "Evangelismos"
  • Athens, Greece
    • General Hospital of Athens "Gennimatas"
  • Athens, Greece
    • General Hospital of Athens "Laiko"
  • Thessaloníki, Greece
    • General Hospital of Athens "Ippokratio"
• Hungary
  • Budapest, Hungary
    • Semmelweis University Faculty of Medicine
  • Budapest, Hungary
    • Military Health Center, Division of Endocrinology
  • Pécs, Hungary
    • University of Pecs Medical School
• Italy
  • Napoli, Italy
    • Azienda Ospedaliera Universitaria Federico II
• New Zealand
  • Takapuna, New Zealand
    • Waitemata District Health Board, North Shore Hospital
  • Wellington, New Zealand
    • Endocrine, Diabetes and Research Centre, Wellington Hospital
• Poland
  • Krakow, Poland
    • Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
• Romania
  • Bucharest, Romania
    • National Institute of Endocrinology "C. I. Parhon"
• Serbia
  • Belgrade, Serbia
    • Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases
• Slovakia
  • Bratislava, Slovakia
    • University Hospital Bratislava
• United Kingdom
  • Coventry, United Kingdom
    • University Hospitals Coventry and Warwickshire NHS Trust
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Gonda Diabetes Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Northwest Pituitary Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Endocrinology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)	The secondary endpoint was the proportion of participants who maintained IGF-1 response, defined as the last assessment before the EoT with IGF-1 ≤1.0× ULN meet responder criteria, in Group 3, 4, and 5 subjects only at W13/EoT	13 Weeks
Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN	Proportion of participants with IGF-1 ≤1.5× ULN at W13/EoT.	13 Weeks

Collaborators and Investigators

• Sponsor: Crinetics Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Acromegaly; Paltusotine; ACROBAT; EDGE
• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Bone Diseases, Endocrine; Acromegaly
• Other Study ID Numbers: CRN00808-03; 2018-002230-20 (EudraCT Number)

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