A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

Acromegaly Clinical Trial

— PATHFNDR-1  

Official title:

A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04837040
• Other study ID #: CRN00808-09
• Secondary ID: 2020-005431-70
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 12, 2021
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Crinetics Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: June 2027
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female subjects =18 years of age

2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 =1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy

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 Treatment naïve or treatment-withdrawn acromegaly subjects

2. Prior treatment with paltusotine

3. Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy

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. Known history of HIV, hepatitis B, or active hepatitis C

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, or 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 currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Paltusotine
Paltusotine, tablets, once daily by mouth
• Placebo
Placebo, tablets, once daily by mouth

Locations

Country	Name	City	State
Argentina	Crinetics Study Site	Caba	Buenos Aires
Argentina	Crinetics Study Site	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Crinetics Study Site	Córdoba
Belgium	Crinetics Study Site	Gent
Brazil	Crinetics Study Site	Curitiba	Paraná
Brazil	Crinetics Study Site	Fortaleza	Ceará
Brazil	Crinetics Study Site	Porto Alegre	Rio Grande Do Sul
Brazil	Crinetics Study Site	Ribeirão Preto	São Paulo
Brazil	Crinetics Study Site	Rio De Janeiro
Brazil	Crinetics Study Site	São Paulo
Brazil	Crinetics Study Site	São Paulo
Bulgaria	Crinetics Study Site	Sofia
France	Crinetics Study Site	Bron
France	Crinetics Study Site	Pessac
Hungary	Crinetics Study Site	Budapest
Hungary	Crinetics Study Site	Pécs
Israel	Crinetics Study Site	Be'er Sheva
Israel	Crinetics Study Site	Petach Tikva
Israel	Crinetics Study Site	Tel Aviv
Italy	Crinetics Study Site	Roma
Peru	Crinetics Study Site	San Isidro	Lima
Poland	Crinetics Study Site	Bydgoszcz
Poland	Crinetics Study Site	Poznan
Poland	Crinetics Study Site	Wroclaw
Russian Federation	Crinetics Study Site	Kazan	Republic Of Tatarstan
Russian Federation	Crinetics Study Site	Kemerovo	Kemerovo Oblast
Russian Federation	Crinetics Study Site	Moscow
Russian Federation	Crinetics Study Site	Moscow
Russian Federation	Crinetics Study Site	Novosibirsk	Novosibirsk Oblast
Russian Federation	Crinetics Study Site	Novosibirsk	Novosibirsk Oblast
Russian Federation	Crinetics Study Site	Samara	Samara Oblast
Serbia	Crinetics Study Site	Belgrade
United Kingdom	Crinetics Study Site	Coventry	West Midlands
United Kingdom	Crinetics Study Site	London
United Kingdom	Crinetics Study Site	Sheffield	South Yorkshire
United States	Crinetics Study Site	Aurora	Colorado
United States	Crinetics Study Site	Baltimore	Maryland
United States	Crinetics Study Site	Boston	Massachusetts
United States	Crinetics Study Site	Los Angeles	California
United States	Crinetics Study Site	Miami	Florida
United States	Crinetics Study Site	Nashville	Tennessee
United States	Crinetics Study Site	Philadelphia	Pennsylvania
United States	Crinetics Study Site	Phoenix	Arizona
United States	Crinetics Study Site	Pittsburgh	Pennsylvania
United States	Crinetics Study Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Crinetics Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Bulgaria,  France,  Hungary,  Israel,  Italy,  Peru,  Poland,  Russian Federation,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who maintain biochemical response in IGF-1 (=1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)		36 Weeks
Secondary	Change from baseline in IGF-1, in units of ULN, to EOR		36 Weeks
Secondary	Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at baseline		34 Weeks
Secondary	Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR		36 Weeks