Paltusotine for Acromegaly

Recruiting at 38 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Crinetics Pharmaceuticals Inc.

Must not be taking: Investigational drugs, QT prolonging

Disqualifiers: Cardiovascular disease, Renal insufficiency, Liver disease, Malignancy, HIV, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

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

Research shows that Paltusotine, an oral drug, can lower levels of growth hormone and IGF-1, which are often high in people with acromegaly. This suggests it may help manage the condition by reducing these hormone levels.¹ ² ³ ⁴ ⁵

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.¹ ² ⁶ ⁷ ⁸

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 help control growth hormone levels, offering a convenient alternative to injectable therapies.¹ ² ⁶ ⁹ ¹⁰

What is the purpose of this trial?

This trial is testing a pill called paltusotine for people with acromegaly, a condition where too much growth hormone is produced. Paltusotine is a new oral treatment being developed for acromegaly and neuroendocrine tumors. The study aims to see if this treatment is safe and effective over a long period.

Eligibility Criteria

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

I am not pregnant or breastfeeding, and I am either unable to have children, past menopause, or using birth control.

Completed one of the parent studies (Acrobat Evolve [CRN00808-02] or Acrobat Edge [CRN00808-03])

Willing to provide signed informed consent

Exclusion Criteria

I have heart conditions or take medications that affect my heart rhythm.

I haven't taken any experimental drugs recently, except paltusotine.

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

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive paltusotine for the treatment of acromegaly

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Paltusotine

Trial Overview The trial is testing the long-term safety and effectiveness of an oral medication called paltusotine for treating acromegaly. It's an open-label phase 2 extension where all participants know they're receiving paltusotine to see how well it works over time and what side effects might occur.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PaltusotineExperimental Treatment1 Intervention