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

Primary Purpose

Acromegaly

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paltusotine
Placebo
Sponsored by
Crinetics Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, PATHFNDR, Paltusotine, CRN00808

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Crinetics Study Site
  • Crinetics Study Site
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  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
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  • Crinetics Study Site
  • Crinetics Study Site (a)
  • Crinetics Study Site (b)
  • Crinetics Study Site
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  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site (a)
  • Crinetics Study Site (b)
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
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  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
  • Crinetics Study Site
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  • Crinetics Study Site
  • Crinetics Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paltusotine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change from baseline in IGF-1, in units of ULN, to EOR
Proportion of subjects with IGF-1 <1.3×ULN at EOR
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.
Proportion of subjects with GH <1.0 ng/mL at Week 22

Full Information

First Posted
January 5, 2022
Last Updated
September 19, 2023
Sponsor
Crinetics Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05192382
Brief Title
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
Acronym
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crinetics Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, PATHFNDR, Paltusotine, CRN00808

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paltusotine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Paltusotine
Other Intervention Name(s)
CRN00808
Intervention Description
Paltusotine, tablets, once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, tablets, once daily by mouth
Primary Outcome Measure Information:
Title
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)
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Change from baseline in IGF-1, in units of ULN, to EOR
Time Frame
24 Weeks
Title
Proportion of subjects with IGF-1 <1.3×ULN at EOR
Time Frame
24 Weeks
Title
Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR
Description
The total ASD score ranges from 0 and 70; lower scores indicate lower symptom burden.
Time Frame
24 Weeks
Title
Proportion of subjects with GH <1.0 ng/mL at Week 22
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects ≥18 years of age Confirmed diagnosis of acromegaly and either medically naïve, not currently treated, or willing to washout during the study screening period. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control Willing to provide signed informed consent Exclusion Criteria: Pituitary radiation therapy within 3 years of Screening Prior treatment with paltusotine History of ineffective or intolerance to octreotide or lanreotide History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer Known history of HIV, hepatitis B, or active hepatitis C History of alcohol or substance abuse in the past 12 months Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities Subjects with symptomatic cholelithiasis 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 Subjects currently or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)
Facility Information:
Facility Name
Crinetics Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Crinetics Study Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Crinetics Study Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Crinetics Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Crinetics Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Crinetics Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Crinetics Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Crinetics Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Crinetics Study Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Crinetics Study Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Crinetics Study Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Crinetics Study Site
City
Caba
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Crinetics Study Site
City
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Crinetics Study Site
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1405BCH
Country
Argentina
Facility Name
Crinetics Study Site
City
Córdoba
ZIP/Postal Code
X5000
Country
Argentina
Facility Name
Crinetics Study Site
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-275
Country
Brazil
Facility Name
Crinetics Study Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130100
Country
Brazil
Facility Name
Crinetics Study Site
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Crinetics Study Site
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Crinetics Study Site
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Crinetics Study Site
City
Rio De Janeiro
ZIP/Postal Code
20231-092
Country
Brazil
Facility Name
Crinetics Study Site
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Crinetics Study Site
City
São Paulo
ZIP/Postal Code
1228000
Country
Brazil
Facility Name
Crinetics Study Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Crinetics Study Site (a)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Crinetics Study Site (b)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Crinetics Study Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Crinetics Study Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Crinetics Study Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Crinetics Study Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Crinetics Study Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410003
Country
China
Facility Name
Crinetics Study Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250063
Country
China
Facility Name
Crinetics Study Site
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Crinetics Study Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Crinetics Study Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Crinetics Study Site
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Crinetics Study Site
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Crinetics Study Site
City
Marseille
ZIP/Postal Code
13395
Country
France
Facility Name
Crinetics Study Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Crinetics Study Site
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Crinetics Study Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Crinetics Study Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Crinetics Study Site
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Crinetics Study Site
City
München
ZIP/Postal Code
81667
Country
Germany
Facility Name
Crinetics Study Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Crinetics Study Site
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Crinetics Study Site (a)
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Crinetics Study Site (b)
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Crinetics Study Site
City
Thessaloníki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Crinetics Study Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Crinetics Study Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Crinetics Study Site
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Crinetics Study Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
11060
Country
India
Facility Name
Crinetics Study Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Crinetics Study Site
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
Crinetics Study Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Crinetics Study Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Crinetics Study Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Crinetics Study Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Crinetics Study Site
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Crinetics Study Site
City
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Crinetics Study Site
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Crinetics Study Site
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Crinetics Study Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Crinetics Study Site
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Crinetics Study Site
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Crinetics Study Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Crinetics Study Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Crinetics Study Site
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Facility Name
Crinetics Study Site
City
Poznań
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Crinetics Study Site
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Crinetics Study Site
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Crinetics Study Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Crinetics Study Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Crinetics Study Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Crinetics Study Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Crinetics Study Site
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S102JF
Country
United Kingdom
Facility Name
Crinetics Study Site
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Crinetics Study Site
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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