REFER PATIENTS

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.

Visit clinicaltrials.gov

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.

Visit clinicaltrials.gov

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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