What side effects are associated with this type of intervention?

Common treatments for acromegaly, such as somatostatin analogs (e.g., octreotide, lanreotide) and growth hormone receptor antagonists (e.g., pegvisomant), often have side effects. Somatostatin analogs can cause gastrointestinal issues like nausea, diarrhea, and abdominal pain, as well as gallstones and injection site reactions. Pegvisomant may lead to liver enzyme abnormalities, injection site reactions, and potential changes in blood sugar levels. These side effects are important to consider when discussing treatment options with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several somatostatin analogs for the treatment of Acromegaly, which are similar to Paltusotine in their mechanism of action. These include octreotide (Sandostatin), lanreotide (Somatuline Depot), and pasireotide (Signifor). These drugs work by mimicking somatostatin, a hormone that inhibits the release of growth hormone, thereby helping to control the symptoms of Acromegaly.

What other types of research exist?

Promising novel alternatives to Paltusotine for Acromegaly patients include: 1) Somatostatin analogs such as octreotide and lanreotide, which are well-established but continue to be refined. 2) Pasireotide, a newer somatostatin analog with a broader receptor affinity, offering potential benefits for patients not responding to other treatments. 3) Pegvisomant, a growth hormone receptor antagonist, which is effective in normalizing IGF-1 levels. 4) Combination therapies involving somatostatin analogs and growth hormone receptor antagonists, which are being explored for enhanced efficacy. Patients should discuss these options with their healthcare provider to determine the best individualized treatment plan.

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Somatostatin Analog

Paltusotine for Acromegaly (PATHFNDR-2 Trial)

Phase 3

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

Pituitary radiation therapy within 3 years of Screening

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

The trial is testing Paltusotine's safety and effectiveness compared to a placebo in treating acromegaly. It's a randomized study where participants will either receive the actual drug or a placebo without knowing which one they're getting.

What are the potential side effects?

Possible side effects of Paltusotine may include digestive issues, gallstones symptoms, changes in blood sugar levels, fatigue, headache, joint pain or reactions at the injection site. Heart rhythm abnormalities could also occur.

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 not had pituitary radiation therapy in the last 3 years.

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

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I have been treated with paltusotine before.

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I have had a bad reaction or no response to octreotide or lanreotide.

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I have a history of HIV, hepatitis B, or active hepatitis C.

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I have painful gallstones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PaltusotineExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paltusotine

2018

Completed Phase 2

~60

0 / 7Eligibility 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

The most common treatments for Acromegaly, such as somatostatin analogs (e.g., octreotide, lanreotide) and newer agents like paltusotine, work by mimicking the action of somatostatin, a hormone that inhibits growth hormone (GH) release. These treatments bind to somatostatin receptors, particularly type 2, on pituitary tumor cells, reducing GH secretion and subsequently lowering insulin-like growth factor 1 (IGF-1) levels. This is crucial for Acromegaly patients as it helps control the excessive growth and metabolic abnormalities caused by high GH and IGF-1 levels, thereby alleviating symptoms and preventing complications.