Phase 3 study of
paltusotine, an investigational treatment for acromegaly
ACROMEGALY TREATMENT: 24 HOURS • 1 DOSE
The PATHFNDER study is recruiting patients to participate in clinical research for once-daily paltusotine for the treatment of acromegaly. If the study is successful, paltusotine could be approved as the only ONCE-DAILY, ORAL therapy that gives patients looking for another treatment option an alternative to injections or twice-daily oral medications.
As a study participant, you could play an important role in advancing the options available for acromegaly treatment for yourself and many others living with this rare disease.
The purpose of the PATHFNDR study 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 confirmed-active acromegaly
STUDY PARTICIPANTS MAY RECEIVE
- Study-related care and study medication at no cost
- Reimbursement for travel for yourself and a care partner
Each PATHFNDR study includes a Screening Period and a Treatment Period. The number of weeks in each period depends on the study. Participants 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).
The Screening Period is between 2 and 16 weeks and may include up to 3 visits to the study site. The Treatment Period is 24 or 36 weeks with up to 11 planned visits to the study site.
At the end of the Treatment Period, participants 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 participants will receive paltusotine.
Patients who complete the OLE study will be asked to return four weeks after the last treatment for one final, end-of-study, follow-up visit.
Download and share a PDF brochure to review with your family, doctor, or others who may be interested in this study.
PATIENT ENROLLMENT CONCLUDED
- Treatment for acromegaly aims to lower certain hormones in the body – insulin-like growth factor 1 (IGF-1) and growth hormone (GH) – and also reduce symptoms of acromegaly.
- Surgery is the usual first-line treatment for acromegaly. When symptoms continue after surgical treatment, 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 oral medications, 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.
- This is Phase 3 clinical study testing an investigational medication.
- The study team can explain the possible benefits and risks of participating in a study.
- You do not have to take part in any study. If you decide to participate in one of these trials, 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 provided at no cost.
- A team of medical professionals will monitor your acromegaly and your overall health throughout the study.
Clinical trials play an important role in the discovery of new treatments, therapies, and procedures for diseases and conditions. Their ultimate goal is to improve health outcomes.
For More Information
To learn more about this study or paltusotine, contact the study team at the link 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.