Acromegaly Treatment: 24 hours • 1 dose

The PATHFNDR studies are recruiting patients to participate in clinical research for once-daily paltusotine for the treatment of acromegaly. Paltusotine could be the only once-daily, oral therapy that gives patients who are looking for an alternative to injections or twice-daily orals another treatment option.

As a study participant, you could play an important role in making acromegaly treatment easier for yourself and many others living with this rare disease.

About the Study

The purpose of the PATHFNDR studies is to see if Crinetics Pharmaceuticals’ investigational medication, paltusotine, is safe and effective in patients with acromegaly.

Who Can Participate?

You may be able to participate in this study if you:

  • Are 18 years of age or older
  • Have medically stable, confirmed-active acromegaly

This study includes a Screening Period and a Treatment Period. The Screening Period is up to 12 weeks and consists of 2 to 3 visits. After the Screening Period, subjects will be enrolled in a 36-week Treatment Period with approximately 11 planned visits.

Subjects will be divided by chance in a 1:1 ratio to receive either paltusotine or placebo (placebo tablets will look identical to the paltusotine tablets but not contain paltusotine or any other study medication).

At the end of the Treatment Period, subjects who in the opinion of the investigator may benefit from treatment with paltusotine, may be enrolled in a long-term, open label extension (OLE) for up to 96 weeks. During the OLE, all subjects will receive paltusotine.

  • This is a Phase 3 clinical study testing an investigational medication.
  • The study team can explain the possible benefits and risks of participating in this study.
  • You do not have to take part in this study. If you decide to participate in this trial, you can choose to discontinue your involvement at any time.
  • Participants are not paid to take part in the study, but the treatment, lab tests, and safety assessments are available at no cost.
  • A team of medical professionals will monitor your acromegaly and your overall health throughout the study.
  • Treatment for acromegaly aims to lower certain hormones – insulin-like growth factor 1 (IGF-1) and growth hormone (GH) – in the body and also reduce symptoms of acromegaly.
  • When surgery, which is the usual first-line treatment, fails, medical treatment in the form of an injectable is often used.
  • To our knowledge, paltusotine is the first nonpeptide once daily oral somatostatin agonist being evaluated for the treatment of acromegaly.
  • For patients looking for an alternative to injections or twice-daily orals, paltusotine may reduce the burden of acromegaly treatment. Additionally, it may allow your doctor to determine an optimized dosing regimen more quickly compared with existing therapies.

Download And Share

You can download PDF versions of the information on this site to send to others who may be interested in the PATHFNDR studies.

PATHFNDR-1

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PATHFNDR-2

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For More Information

To learn more about this study or paltusotine, contact the study team at the url below. Study participation is voluntary. By contacting the study team, you are not obligated to take part in the study nor complete the study if you decide to participate.

More Information