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

Phase 2

Completed

• Conditions: Acromegaly
• Interventions: Drug: Paltusotine

• Registration Number: NCT03789656
• Lead Sponsor: Crinetics Pharmaceuticals Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2018-12-27
• Study First Posted: 2018-12-28
• Study Start: 2019-03-12
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-31
• Disposition First Submitted: 2021-07-27
• Results First Submitted: 2024-09-11
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Results First Posted: 2025-02-17
• Disposition First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paltusotine	Paltusotine	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level	13 Weeks	Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)	13 Weeks	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
Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN	13 Weeks	Proportion of participants with IGF-1 ≤1.5× ULN at W13/EoT.

Trial Locations

Locations (26)

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"; 🇬🇷 Thessaloníki, Greece

Military Health Center, Division of Endocrinology; 🇭🇺 Budapest, Hungary

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

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