Clinical trial NCT05192382: A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acromegaly
Keywords: Acromegaly
PATHFNDR
Paltusotine
CRN00808
Lead sponsor: Crinetics Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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)
timeFrame: 24 Weeks
Secondary outcomes:
measure: Change from baseline in IGF-1, in units of ULN, to EOR
timeFrame: 24 Weeks
measure: Proportion of subjects with IGF-1 <1.3×ULN at EOR
timeFrame: 24 Weeks
measure: Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR
timeFrame: 24 Weeks
measure: Proportion of subjects with GH <1.0 ng/mL at Week 22
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Crinetics Study Site
state: Colorado
city: Boston
country: United States
facility: Crinetics Study Site
state: Massachusetts
city: Columbus
country: United States
facility: Crinetics Study Site
state: Ohio
city: Portland
country: United States
facility: Crinetics Study Site
state: Oregon
city: Philadelphia
country: United States
facility: Crinetics Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Crinetics Study Site
state: Pennsylvania
city: Caba
country: Argentina
facility: Crinetics Study Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Crinetics Study Site
city: Caba
country: Argentina
facility: Crinetics Study Site
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Crinetics Study Site
city: Córdoba
country: Argentina
facility: Crinetics Study Site
city: Fortaleza
country: Brazil
facility: Crinetics Study Site
state: Ceará
city: Belo Horizonte
country: Brazil
facility: Crinetics Study Site
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Crinetics Study Site
state: Paraná
city: Botucatu
country: Brazil
facility: Crinetics Study Site
state: São Paulo
city: Campinas
country: Brazil
facility: Crinetics Study Site
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Crinetics Study Site
city: São Paulo
country: Brazil
facility: Crinetics Study Site
city: São Paulo
country: Brazil
facility: Crinetics Study Site
city: Sofia
country: Bulgaria
facility: Crinetics Study Site
city: Beijing
country: China
facility: Crinetics Study Site (b)
state: Beijing
city: Guangzhou
country: China
facility: Crinetics Study Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Crinetics Study Site
state: Hebei
city: Zhengzhou
country: China
facility: Crinetics Study Site
state: Henan
city: Wuhan
country: China
facility: Crinetics Study Site
state: Hubei
city: Changsha
country: China
facility: Crinetics Study Site
state: Hunan
city: Jinan
country: China
facility: Crinetics Study Site
state: Shandong
city: Xi'an
country: China
facility: Crinetics Study Site
state: Shanxi
city: Chengdu
country: China
facility: Crinetics Study Site
state: Sichuan
city: Hangzhou
country: China
facility: Crinetics Study Site
state: Zhejiang
city: Marseille
country: France
facility: Crinetics Study Site
city: Pessac
country: France
facility: Crinetics Study Site
city: Toulouse
country: France
facility: Crinetics Study Site
city: Aachen
country: Germany
facility: Crinetics Study Site
city: Berlin
country: Germany
facility: Crinetics Study Site
city: München
country: Germany
facility: Crinetics Study Site
city: München
country: Germany
facility: Crinetics Study Site
city: Würzburg
country: Germany
facility: Crinetics Study Site
city: Athens
country: Greece
facility: Crinetics Study Site
city: Athens
country: Greece
facility: Crinetics Study Site (b)
city: Thessaloníki
country: Greece
facility: Crinetics Study Site
city: Budapest
country: Hungary
facility: Crinetics Study Site
city: Budapest
country: Hungary
facility: Crinetics Study Site
city: Pécs
country: Hungary
facility: Crinetics Study Site
city: Bangalore
country: India
facility: Crinetics Study Site
state: Karnataka
city: Belgaum
country: India
facility: Crinetics Study Site
state: Karnataka
city: Kochi
country: India
facility: Crinetics Study Site
state: Kerala
city: Mumbai
country: India
facility: Crinetics Study Site
state: Maharashtra
city: Chandigarh
country: India
facility: Crinetics Study Site
city: Delhi
country: India
facility: Crinetics Study Site
city: Petah Tikva
country: Israel
facility: Crinetics Study Site
city: Roma
country: Italy
facility: Crinetics Study Site
city: Bydgoszcz
country: Poland
facility: Crinetics Study Site
city: Poznań
country: Poland
facility: Crinetics Study Site
city: Wrocław
country: Poland
facility: Crinetics Study Site
city: Barcelona
country: Spain
facility: Crinetics Study Site
city: London
country: United Kingdom
facility: Crinetics Study Site
Study officials:
References: