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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
PATHFNDR-2 Trial Summary
This trial is testing a new drug for people with acromegaly who haven't been helped by other treatments. The drug is paltusotine, and it's given orally. The trial will compare the safety and effectiveness of paltusotine to a placebo.
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.Check my eligibility
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.See study design
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.
PATHFNDR-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding, and I am either unable to have children, past menopause, or using birth control.
PATHFNDR-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects who achieve biochemical response in IGF-1 (≤1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)
Secondary outcome measures
Change from baseline in IGF-1, in units of ULN, to EOR
Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR
Proportion of subjects with GH <1.0 ng/mL at Week 22
+1 morePATHFNDR-2 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
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.
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Who is running the clinical trial?
Crinetics Pharmaceuticals Inc.Lead Sponsor
11 Previous Clinical Trials
500 Total Patients Enrolled
4 Trials studying Acromegaly
161 Patients Enrolled for Acromegaly
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had pituitary radiation therapy in the last 3 years.I have acromegaly and am either not on treatment or willing to stop my current treatment for the study.I have acromegaly and am either not on treatment or willing to stop my current treatment for the study.I have heart conditions or take medications that affect my heart rhythm.I have used pegvisomant, cabergoline, or pasireotide LAR recently.I have been treated with paltusotine before.I have had a bad reaction or no response to octreotide or lanreotide.I have a history of HIV, hepatitis B, or active hepatitis C.I am not pregnant or breastfeeding, and I am either unable to have children, past menopause, or using birth control.You have had problems with drinking too much alcohol or using drugs in the last year.I have not had cancer, except for certain skin cancers, in the last 5 years.I am 18 years old or older.I have painful gallstones.
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Paltusotine
- Group 2: Placebo
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