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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 below
Select...
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 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

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 more

PATHFNDR-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

Find a Location

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

Paltusotine (Somatostatin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05192382 — Phase 3
Acromegaly Clinical Trial 2023: Paltusotine Highlights & Side Effects. Trial Name: NCT05192382 — Phase 3
Paltusotine (Somatostatin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05192382 — Phase 3
Acromegaly Research Study Groups: Paltusotine, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What precedent exists for the use of Paltusotine in medical trials?

"Paltusotine was first studied in 2019 at the Crinetics Study Site. Out of the 18,267 completed clinical trials, 3 are actively recruiting patients. A large majority of these studies are based in Los Angeles, California."

Answered by AI

When can US patients expect Paltusotine to be available?

"Paltusotine is believed to be safe based on our scoring system which takes into account that this is a Phase 3 trial."

Answered by AI

Are they currently looking for participants in this study?

"Yes, you're correct. The clinical trial is currently looking for patients that meet the requirements. The study was first posted on December 17th, 2021 and was last edited on October 5th, 2022. The research is enrolling a total of 76 individuals between 8 locations."

Answered by AI

Are there many research centers conducting this trial in Canada?

"There are 11 sites total where this trial is enrolling patients. In addition to Cedars-Sinai Medical Center in Los Angeles, California and The Lundquist Institute in Portland, Oregon, Allegheny Endocrinology Associates in Torrance, Ohio are enrolling patients for this study."

Answered by AI

Is this research fresh and new?

"Paltusotine is being trialed in 3 live trials across 35 cities and 20 countries. The first clinical trial for Paltusotine was conducted in 2019. The study, sponsored by Crinetics Pharmaceuticals Inc., involved 43 participants and completed its Phase 2 drug approval stage. Since 2019 years, 18267 trials have been completed."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Crinetics Study Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
2021. "A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05192382.
~33 spots leftby Apr 2025
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