Paltusotine for Acromegaly
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called paltusotine for individuals with acromegaly, a condition characterized by excessive growth hormone production, resulting in enlarged hands, feet, and facial features. The trial aims to assess the long-term safety and effectiveness of paltusotine. Participants from earlier related studies who have acromegaly without other major health issues may be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use any investigational drugs other than paltusotine within 30 days before screening, and certain cardiovascular medications may not be allowed.
Is there any evidence suggesting that paltusotine is likely to be safe for humans?
Research has shown that paltusotine is generally well-tolerated. One study found its safety comparable to other treatments for similar conditions, indicating it functions like existing therapies. Another study demonstrated that paltusotine was well-tolerated over two years, suggesting promise for long-term use.
These studies have reported no major safety concerns, suggesting that paltusotine might be a safe option for people with acromegaly, although further research is necessary to confirm this. Prospective trial participants may find these findings reassuring.12345Why do researchers think this study treatment might be promising for acromegaly?
Paltusotine is unique because it offers a new way to treat acromegaly by being taken orally, unlike the standard treatments that often require injections. Most current medications, like somatostatin analogs, need to be injected, which can be inconvenient and uncomfortable for patients. Paltusotine works as a non-peptide somatostatin receptor ligand, potentially offering a similar therapeutic effect without the need for needles. Researchers are excited about this treatment because it could improve patient quality of life by providing an easier and more convenient treatment option.
What evidence suggests that paltusotine might be an effective treatment for acromegaly?
Research shows that paltusotine, the investigational treatment in this trial, effectively treats acromegaly by stabilizing insulin-like growth factor-1 (IGF-1) levels, crucial for managing the condition. Studies have found that patients who switched from injections to paltusotine maintained their IGF-1 levels. In one study, 83.3% of patients using paltusotine achieved the main goal of controlling the disease. Long-term research suggests that paltusotine can keep the body's chemical balance steady over time. Overall, paltusotine has shown positive results in effectively managing acromegaly.12467
Are You a Good Fit for This Trial?
This trial is for individuals with acromegaly who finished a previous paltusotine study, are not pregnant or breastfeeding, and use effective birth control if necessary. Excluded are those with recent investigational drug use, significant health issues that could affect safety or completion of the study, symptomatic gallstones, serious heart disease, kidney or liver conditions, pituitary radiation post-parent studies, certain cancers within 5 years (except some skin cancers), and substance abuse in the past year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive paltusotine for the treatment of acromegaly
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Paltusotine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Crinetics Pharmaceuticals Inc.
Lead Sponsor