Phase 3 studies of paltusotine, an investigational treatment for acromegaly
Crinetics is recruiting patients to participate in studies of ONCE-DAILY paltusotine for the treatment of acromegaly.
The PATHFNDR studies are Phase 3, randomized, placebo-controlled, multi-center studies to evaluate the safety and efficacy of paltusotine, a nonpeptide, orally bioavailable somatostatin receptor 2 (SST2) agonist taken once daily. In Phase 2 studies, paltusotine was shown to maintain GH and IGF-1 levels in patients with acromegaly who were previously on octreotide LAR or lanreotide depot monotherapy.
If you have acromegaly patients interested in a ONCE-DAILY, ORAL therapy, please refer them to the PATHFNDR studies intake page to check eligibility and to be contacted by the study team.
PATHFNDR-1: A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly in Patients Treated with Long-acting Somatostatin Receptor Ligands
To be eligible, patients must:
- Be 18 years of age or older
- Have confirmed-active acromegaly
Key exclusion criteria:
- History of pituitary radiation therapy
- Subjects with adrenal insufficiency who are not receiving adequate adrenal replacement therapy at the time of screening, as determined by the Investigator
- Pituitary adenoma that might require immediate surgical treatment or pituitary carcinoma
VISIT THE PATHFNDR-1 TRIAL PAGE ON CLINICALTRIALS.GOV
Review the study summary, outcome measures, inclusion/exclusion criteria and more.
PATHFNDR-2: A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly in Non-pharmacologically Treated Patients
To be eligible, patients must:
- Be 18 years of age or older
- Have confirmed-active acromegaly
- Fall into one of three treatment groups:
- Never treated with acromegaly medication
- Previously treated with acromegaly medication, but has stopped acromegaly medication at least 4 months prior to screening
- Be on an approved, stable dose of octreotide monotherapy for at least 3 months AND be willing to washout of their medication during the screening period
Key exclusion criteria:
- History of pituitary radiation therapy within 3 years of screening
- Subjects with adrenal insufficiency, diabetes insipidus, or central hypogonadism who are not receiving adequate hormone replacement therapy at the time of screening, as determined by the Investigator
- Pituitary adenoma that might require immediate surgical treatment or pituitary carcinoma
VISIT THE PATHFNDR-2 TRIAL PAGE ON CLINICALTRIALS.GOV
Review the study summary, outcome measures, inclusion/exclusion criteria and more.
Share This Information
The PATHFNDR brochures answer common questions patients have when considering enrollment in a study. You can download it here and forward it to any of your patients who express interest in learning more.
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If you’d like to speak with someone about the PATHFNDR studies or want help referring patients, please reach out to Patient Advocacy & Outreach, by clicking below.
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