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

Phase 3

Active, not recruiting

• Conditions: Acromegaly
• Interventions: Drug: Placebo; Drug: Paltusotine

• Registration Number: NCT05192382
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-17
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-14
• Primary Completion: 2024-01-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 111

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Paltusotine	Paltusotine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in IGF-1, in units of ULN, to EOR	24 Weeks
Proportion of subjects with IGF-1 <1.3×ULN at EOR	24 Weeks
Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR	24 Weeks	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	24 Weeks

Trial Locations

Locations (3)

Crinetics Study Site; 🇬🇧 London, United Kingdom

Crinetics Study Site (a); 🇬🇷 Athens, Greece

Crinetics Study Site (b); 🇬🇷 Athens, Greece