A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)

Acromegaly Clinical Trial

— PATHFNDR-2  

Official title:

A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05192382
• Other study ID #: CRN00808-08
• Secondary ID: 2021-001703-32
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 17, 2021
• Est. completion date: January 2028

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 (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Est. completion date: January 2028
• Est. primary completion date: January 20, 2024
• 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 either medically naïve, not currently treated, or willing to washout during the study screening period.

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. Pituitary radiation therapy within 3 years of Screening

2. Prior treatment with paltusotine

3. History of ineffective or intolerance to octreotide or lanreotide

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 or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)

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	Caba
Argentina	Crinetics Study Site	Caba
Argentina	Crinetics Study Site	Ciudad Autonoma de Buenos Aires
Argentina	Crinetics Study Site	Córdoba
Brazil	Crinetics Study Site	Belo Horizonte	Minas Gerais
Brazil	Crinetics Study Site	Botucatu	São Paulo
Brazil	Crinetics Study Site	Campinas	São Paulo
Brazil	Crinetics Study Site	Curitiba	Paraná
Brazil	Crinetics Study Site	Fortaleza	Ceará
Brazil	Crinetics Study Site	Rio De Janeiro
Brazil	Crinetics Study Site	São Paulo
Brazil	Crinetics Study Site	São Paulo
Bulgaria	Crinetics Study Site	Sofia
China	Crinetics Study Site (a)	Beijing	Beijing
China	Crinetics Study Site (b)	Beijing	Beijing
China	Crinetics Study Site	Changsha	Hunan
China	Crinetics Study Site	Chengdu	Sichuan
China	Crinetics Study Site	Guangzhou	Guangdong
China	Crinetics Study Site	Hangzhou	Zhejiang
China	Crinetics Study Site	Jinan	Shandong
China	Crinetics Study Site	Shijiazhuang	Hebei
China	Crinetics Study Site	Wuhan	Hubei
China	Crinetics Study Site	Xi'an	Shanxi
China	Crinetics Study Site	Zhengzhou	Henan
France	Crinetics Study Site	Bron
France	Crinetics Study Site	Le Kremlin-Bicêtre
France	Crinetics Study Site	Marseille
France	Crinetics Study Site	Pessac
France	Crinetics Study Site	Toulouse
Germany	Crinetics Study Site	Aachen
Germany	Crinetics Study Site	Berlin
Germany	Crinetics Study Site	München
Germany	Crinetics Study Site	München
Germany	Crinetics Study Site	Würzburg
Greece	Crinetics Study Site	Athens
Greece	Crinetics Study Site (a)	Athens
Greece	Crinetics Study Site (b)	Athens
Greece	Crinetics Study Site	Thessaloníki
Hungary	Crinetics Study Site	Budapest
Hungary	Crinetics Study Site	Budapest
Hungary	Crinetics Study Site	Pécs
India	Crinetics Study Site	Bangalore	Karnataka
India	Crinetics Study Site	Belgaum	Karnataka
India	Crinetics Study Site	Chandigarh
India	Crinetics Study Site	Delhi
India	Crinetics Study Site	Kochi	Kerala
India	Crinetics Study Site	Kolkata	West Bengal
India	Crinetics Study Site	Mumbai	Maharashtra
India	Crinetics Study Site	New Delhi	Delhi
India	Crinetics Study Site	Vellore	Tamil Nadu
Israel	Crinetics Study Site	Be'er Sheva
Israel	Crinetics Study Site	Petah Tikva
Israel	Crinetics Study Site	Tel Aviv
Italy	Crinetics Study Site	Messina
Italy	Crinetics Study Site	Milano
Italy	Crinetics Study Site	Roma
Italy	Crinetics Study Site	Torino
Poland	Crinetics Study Site	Bydgoszcz
Poland	Crinetics Study Site	Poznan
Poland	Crinetics Study Site	Wroclaw
Spain	Crinetics Study Site	Barcelona
Spain	Crinetics Study Site	Barcelona
Spain	Crinetics Study Site	Santiago De Compostela	A Coruña
Spain	Crinetics Study Site	Sevilla
Spain	Crinetics Study Site	Valencia
United Kingdom	Crinetics Study Site	Birmingham	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	Boston	Massachusetts
United States	Crinetics Study Site	Columbus	Ohio
United States	Crinetics Study Site	Los Angeles	California
United States	Crinetics Study Site	Miami	Florida
United States	Crinetics Study Site	Philadelphia	Pennsylvania
United States	Crinetics Study Site	Pittsburgh	Pennsylvania
United States	Crinetics Study Site	Pittsburgh	Pennsylvania
United States	Crinetics Study Site	Portland	Oregon
United States	Crinetics Study Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Crinetics Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  China,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve biochemical response in IGF-1 (=1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)		24 Weeks
Secondary	Change from baseline in IGF-1, in units of ULN, to EOR		24 Weeks
Secondary	Proportion of subjects with IGF-1 <1.3×ULN at EOR		24 Weeks
Secondary	Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR	The total ASD score ranges from 0 and 70; lower scores indicate lower symptom burden.	24 Weeks
Secondary	Proportion of subjects with GH <1.0 ng/mL at Week 22		24 Weeks