A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Acromegaly
In brief
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.
Key facts
- Study ID
- NCT04837040
- Run by
- Crinetics Pharmaceuticals Inc.
- People needed
- 58
- Starts
- 2021-05-12
- Expected to finish
- 2026-05-29
- Last updated by the study team
- 2026-07-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female subjects ≥18 years of age
- Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
- 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
You may not qualify if…
- Treatment naïve or treatment-withdrawn acromegaly subjects
- Prior treatment with paltusotine
- Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
- 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 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)
Where it is running
- Crinetics Study Site — Los Angeles, California, United States
- Crinetics Study Site — Torrance, California, United States
- Crinetics Study Site — Baltimore, Maryland, United States
- Crinetics Study Site — Boston, Massachusetts, United States
- Crinetics Study Site — Philadelphia, Pennsylvania, United States
- Crinetics Study Site — Pittsburgh, Pennsylvania, United States
- Crinetics Study Site — Nashville, Tennessee, United States
- Crinetics Study Site — CABA, Buenos Aires, Argentina
- Crinetics Study Site — Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
- Crinetics Study Site — Córdoba, Argentina
- Crinetics Study Site — Ghent, Belgium
- Crinetics Study Site — Fortaleza, Ceará, Brazil
- Crinetics Study Site — Curitiba, Paraná, Brazil
- Crinetics Study Site — Porto Alegre, Rio Grande do Sul, Brazil
- Crinetics Study Site — Rio de Janeiro, Brazil
- Crinetics Study Site — Rio de Janeiro, Brazil
- Crinetics Study Site — Sofia, Bulgaria
- Crinetics Study Site — Bron, France
- Crinetics Study Site — Pessac, France
- Crinetics Study Site — Budapest, Hungary
- Crinetics Study Site — Pécs, Hungary
- Crinetics Study Site — Beersheba, Israel
- Crinetics Study Site — Petah Tikva, Israel
- Crinetics Study Site — Roma, Italy
- Crinetics Study Site — San Isidro, Lima region, Peru
Full record on ClinicalTrials.gov
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