Paltusotine for Acromegaly

(PATHFNDR-1 Trial)

Recruiting at 122 trial locations

Overseen By Crinetics Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Crinetics Pharmaceuticals Inc.

Must be taking: Somatostatin receptor ligands

Must not be taking: Pasireotide, Pegvisomant, Dopamine agonists

Disqualifiers: Malignancy, HIV, Hepatitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

58 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing paltusotine, a pill that mimics a natural hormone, in patients with acromegaly. The goal is to see if it can help control their high growth hormone levels. Paltusotine is being developed for the treatment of acromegaly and neuroendocrine tumors.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable dose of somatostatin receptor ligand therapy, but you must stop taking pasireotide LAR, pegvisomant, dopamine agonists, or short-acting somatostatin analogs before joining. If you're on these, you'll need to stop them 12 to 24 weeks before the trial.

What data supports the effectiveness of the drug Paltusotine for treating acromegaly?

Research shows that Paltusotine, an oral drug, is being developed to treat acromegaly by targeting specific receptors in the body. Similar drugs, like somatostatin analogs, have been effective in reducing tumor size and controlling symptoms in acromegaly patients. ^{1 2 3 4 5}

Is Paltusotine safe for humans?

Paltusotine has been studied for safety in both patients with acromegaly and healthy volunteers. It is an oral medication being developed for acromegaly and neuroendocrine tumors, and safety data from these studies suggest it is generally safe for human use. ^{1 4 5 6 7}

How is the drug Paltusotine different from other treatments for acromegaly?

Paltusotine is unique because it is an oral, once-daily medication that targets somatostatin receptor type 2 (SST2) to suppress growth hormone and IGF-1 levels, unlike traditional treatments that often require injections. ^{3 4 5 6 8}

Eligibility Criteria

Adults diagnosed with acromegaly, previously treated with somatostatin receptor ligand therapy and have their condition under control. Participants must not be pregnant or breastfeeding, should use birth control if necessary, and provide consent. Excluded are those who've used investigational drugs recently, have significant health risks, a history of certain infections or cancer (except some skin cancers), substance abuse within the last year, or specific heart conditions.

Inclusion Criteria

My acromegaly is under control with stable medication.

Willing to provide signed informed consent

I am 18 years old or older.

Exclusion Criteria

I haven't taken any experimental drugs recently.

I had pituitary surgery within the last 6 months or have had pituitary radiation therapy.

I have not had cancer, except for certain skin cancers, in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive paltusotine or placebo to evaluate safety and efficacy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Paltusotine
• Placebo

Trial Overview The trial is testing Paltusotine's safety and effectiveness compared to a placebo in adults with acromegaly who were on stable doses of somatostatin receptor ligands. It's randomized and controlled; participants won't know if they're getting the actual drug or a dummy pill.

Participant Groups

Group I: Paltusotine Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Crinetics Pharmaceuticals Inc.

Lead Sponsor

Trials

13

Recruited

760+

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of tumor shrinkage after primary therapy with somatostatin analogs in acromegaly: a prospective study in 99 patients. [2016]

2. Brazil pubmed.ncbi.nlm.nih.gov

Biochemical acromegaly in patients with prolactinoma during treatment with dopaminergic agonists. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Long-term treatment of acromegaly with the somatostatin analogue SR-lanreotide. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

ACROBAT Edge: Safety and Efficacy of Switching Injected SRLs to Oral Paltusotine in Patients With Acromegaly. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

Current status and future directions of pharmacological therapy for acromegaly. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Paltusotine, a novel oral once-daily nonpeptide SST2 receptor agonist, suppresses GH and IGF-1 in healthy volunteers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

New formulations and approaches in the medical treatment of acromegaly. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Optimizing somatostatin analog therapy in acromegaly: long-acting formulations. [2019]