Paltusotine for Acromegaly
(PATHFNDR-2 Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a new pill called paltusotine for people with acromegaly who haven't tried other treatments. The pill works by lowering growth hormone levels in the body.
Will I have to stop taking my current medications?
The trial requires participants to either be medically naïve, not currently treated, or willing to stop their current medications during the study screening period. If you are on certain medications, you may need to stop taking them to participate.
What data supports the effectiveness of the drug Paltusotine for treating acromegaly?
Is Paltusotine safe for humans?
Paltusotine has been studied for safety in healthy volunteers and patients with acromegaly, showing it is generally safe for human use. It is an oral medication being developed to treat acromegaly and neuroendocrine tumors, and no major safety concerns have been reported in the studies available.12678
How is the drug Paltusotine different from other treatments for acromegaly?
Paltusotine is unique because it is an oral medication taken once daily, unlike many other treatments for acromegaly that require injections. It works by targeting the somatostatin receptor subtype 2 (SST2) to suppress growth hormone (GH) and insulin-like growth factor 1 (IGF-1) levels, which are often elevated in acromegaly.126910
Eligibility Criteria
This trial is for adults over 18 with acromegaly who haven't been treated pharmacologically or are willing to stop current treatments during the study. Participants must not be pregnant, should use birth control if necessary, and cannot have had certain cancer treatments or suffer from specific heart conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either paltusotine or placebo for the treatment of acromegaly
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Paltusotine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Crinetics Pharmaceuticals Inc.
Lead Sponsor