A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
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 (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.
Key facts
- Study ID
- NCT05192382
- Run by
- Crinetics Pharmaceuticals Inc.
- People needed
- 111
- Starts
- 2021-12-17
- Expected to finish
- 2026-06-02
- 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 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
You may not qualify if…
- 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)
Where it is running
- Crinetics Study Site — Boston, Massachusetts, United States
- Crinetics Study Site — Columbus, Ohio, United States
- Crinetics Study Site — Portland, Oregon, United States
- Crinetics Study Site — Philadelphia, Pennsylvania, United States
- Crinetics Study Site — Pittsburgh, Pennsylvania, United States
- Crinetics Study Site — CABA, Buenos Aires, Argentina
- Crinetics Study Site — Buenos Aires, Argentina
- Crinetics Study Site — CABA, Argentina
- Crinetics Study Site — CABA, Argentina
- Crinetics Study Site — Córdoba, Argentina
- Crinetics Study Site — Fortaleza, Ceará, Brazil
- Crinetics Study Site — Belo Horizonte, Minas Gerais, Brazil
- Crinetics Study Site — Curitiba, Paraná, Brazil
- Crinetics Study Site — Botucatu, São Paulo, Brazil
- Crinetics Study Site — Campinas, São Paulo, Brazil
- Crinetics Study Site — Rio de Janeiro, Brazil
- Crinetics Study Site — São Paulo, Brazil
- Crinetics Study Site — São Paulo, Brazil
- Crinetics Study Site — Sofia, Bulgaria
- Crinetics Study Site (b) — Beijing, Beijing Municipality, China
- Crinetics Study Site — Guangzhou, Guangdong, China
- Crinetics Study Site — Shijiazhuang, Hebei, China
- Crinetics Study Site — Zhengzhou, Henan, China
- Crinetics Study Site — Wuhan, Hubei, China
- Crinetics Study Site — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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