What side effects are associated with this type of intervention?

Common treatments for acromegaly, such as somatostatin analogs (e.g., octreotide, lanreotide) and newer agents like pasireotide, often have side effects including gastrointestinal issues (nausea, diarrhea, abdominal pain), gallstones, and injection site reactions. Pasireotide may also cause hyperglycemia and diabetes. These side effects are generally manageable but require monitoring and sometimes additional treatment.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Acromegaly include somatostatin analogs such as octreotide, lanreotide, and pasireotide. These drugs function by mimicking somatostatin, a hormone that inhibits the release of growth hormone, thereby helping to control the symptoms of Acromegaly. Paltusotine, currently being studied, is a selective nonpeptide somatostatin receptor type 2 biased agonist, which represents a similar therapeutic approach.

What other types of research exist?

Promising novel alternatives to Paltusotine for Acromegaly patients in 2024 include newer somatostatin analogs like pasireotide, which targets multiple somatostatin receptor subtypes, and investigational agents such as oral octreotide capsules. These alternatives have shown potential in clinical trials and may offer different efficacy and safety profiles.

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Somatostatin Receptor Agonist

Paltusotine for Acromegaly

Phase 2

Waitlist Available

Research Sponsored by Crinetics Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control

Be older than 18 years old

Must not have

Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities

Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for paltusotine aren't listed here, common ones related to similar treatments include digestive issues like nausea or diarrhea; fatigue; joint pain; changes in blood sugar levels; headache; injection site reactions (if applicable); and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have symptoms from gallstones.

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I do not have serious heart, kidney, or liver diseases.

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I have received pituitary radiation after my last clinical study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PaltusotineExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paltusotine

Not yet FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Acromegaly is commonly treated with somatostatin analogs, such as octreotide and lanreotide, which work by binding to somatostatin receptors and inhibiting the release of growth hormone (GH) from the pituitary gland. Paltusotine, a selective nonpeptide somatostatin receptor type 2 biased agonist, functions similarly by targeting these receptors to reduce GH levels. This mechanism is crucial for Acromegaly patients as it helps to control the excessive growth hormone production that leads to the characteristic symptoms and complications of the disease, such as enlarged tissues and organs, thereby improving their quality of life and reducing the risk of associated health issues.