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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05192382
Recruitment Status : Recruiting
First Posted : January 14, 2022
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Paltusotine Drug: Placebo Phase 3

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Study Type : Interventional
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)
Actual Study Start Date : December 17, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paltusotine Drug: Paltusotine
Paltusotine, tablets, once daily by mouth
Other Name: CRN00808

Placebo Comparator: Placebo Drug: Placebo
Placebo, tablets, once daily by mouth




Primary Outcome Measures :
  1. 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 Measures :
  1. Change from baseline in IGF-1 to EOR [ Time Frame: 24 Weeks ]
  2. Proportion of subjects with IGF-1 <1.3 ng/mL at EOR [ Time Frame: 24 Weeks ]
  3. Proportion of subjects with GH <1.0 ng/mL at Week 22 [ Time Frame: 24 Weeks ]
  4. Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR [ Time Frame: 24 Weeks ]
    The total ASD score ranges from 0 and 70; lower scores indicate lower symptom burden.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05192382


Contacts
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Contact: Crinetics Clinical Trials 833-827-9741 clinicaltrials@crinetics.com

Locations
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United States, California
Crinetics Study Site Recruiting
Los Angeles, California, United States, 90048
Crinetics Study Site Recruiting
Torrance, California, United States, 90502
United States, Ohio
Crinetics Study Site Recruiting
Columbus, Ohio, United States, 43210
United States, Oregon
Crinetics Study Site Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Crinetics Study Site Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Argentina
Crinetics Study Site Recruiting
Caba, Buenos Aires, Argentina, C1012AAR
Crinetics Study Site Recruiting
Caba, Argentina, 1425
Crinetics Study Site Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1405BCH
Crinetics Study Site Recruiting
Córdoba, Argentina, X5000
France
Crinetics Study Site Recruiting
Bron, France, 69677
Crinetics Study Site Recruiting
Le Kremlin-Bicêtre, France, 94275
Crinetics Study Site Recruiting
Marseille, France, 13395
Crinetics Study Site Recruiting
Pessac, France, 33604
Crinetics Study Site Recruiting
Toulouse, France, 31400
Germany
Crinetics Study Site Recruiting
München, Germany, 81667
Crinetics Study Site Recruiting
Würzburg, Germany, 97080
Hungary
Crinetics Study Site Recruiting
Pécs, Hungary, 7624
Italy
Crinetics Study Site Recruiting
Messina, Italy, 98125
Crinetics Study Site Recruiting
Roma, Italy, 00168
Poland
Crinetics Study Site Recruiting
Bydgoszcz, Poland, 85-605
Crinetics Study Site Recruiting
Wrocław, Poland, 50-367
Spain
Crinetics Study Site Recruiting
Barcelona, Spain, 08035
Crinetics Study Site Recruiting
Barcelona, Spain, 08041
Crinetics Study Site Recruiting
Sevilla, Spain, 41013
Crinetics Study Site Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.
Additional Information:
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Responsible Party: Crinetics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT05192382    
Other Study ID Numbers: CRN00808-08
2021-001703-32 ( EudraCT Number )
First Posted: January 14, 2022    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Crinetics Pharmaceuticals Inc.:
Acromegaly
PATHFNDR
Paltusotine
CRN00808
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases