A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

Phase 3

Active, not recruiting

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

• Registration Number: NCT04837040
• Lead Sponsor: Crinetics Pharmaceuticals Inc.

Brief Summary

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Study Start: 2021-05-12
• Primary Completion: 2023-07-10
• Disposition First Posted: 2024-03-29
• Status Verified: 2024-07
• Disposition First Submitted: 2024-07-08
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Male and female subjects ≥18 years of age
2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
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. Treatment naïve or treatment-withdrawn acromegaly subjects
2. Prior treatment with paltusotine
3. Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
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 taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)

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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 maintain biochemical response in IGF-1 (≤1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)	36 Weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at baseline	34 Weeks
Change from baseline in IGF-1, in units of ULN, to EOR	36 Weeks
Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR	36 Weeks

Trial Locations

Locations (1)

Crinetics Study Site; 🇬🇧 London, United Kingdom