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Somatostatin Agonist

Paltusotine for Acromegaly (PATHFNDR-1 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
Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights

PATHFNDR-1 Trial Summary

This trial will study the safety and effectiveness of paltusotine in people with acromegaly who have already been treated with other drugs targeting somatostatin receptors.

Who is the study for?
Adults diagnosed with acromegaly, previously treated with somatostatin receptor ligand therapy and have their condition under control. Participants must not be pregnant or breastfeeding, should use birth control if necessary, and provide consent. Excluded are those who've used investigational drugs recently, have significant health risks, a history of certain infections or cancer (except some skin cancers), substance abuse within the last year, or specific heart conditions.Check my eligibility
What is being tested?
The trial is testing Paltusotine's safety and effectiveness compared to a placebo in adults with acromegaly who were on stable doses of somatostatin receptor ligands. It's randomized and controlled; participants won't know if they're getting the actual drug or a dummy pill.See study design
What are the potential side effects?
Specific side effects for Paltusotine aren't listed here but generally could include digestive issues, changes in blood sugar levels, gallstones symptoms if present before treatment starts, fatigue or allergic reactions.

PATHFNDR-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My acromegaly is under control with stable medication.
Select...
I am not pregnant or breastfeeding, and I cannot become pregnant or am using birth control.
Select...
My acromegaly is under control with stable medication.

PATHFNDR-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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 maintain 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 34, out of those who had GH <1.0 ng/mL at baseline

PATHFNDR-1 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
553 Total Patients Enrolled
4 Trials studying Acromegaly
214 Patients Enrolled for Acromegaly

Media Library

Paltusotine (Somatostatin Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04837040 — Phase 3
Acromegaly Research Study Groups: Paltusotine, Placebo
Acromegaly Clinical Trial 2023: Paltusotine Highlights & Side Effects. Trial Name: NCT04837040 — Phase 3
Paltusotine (Somatostatin Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04837040 — Phase 3

Frequently Asked Questions

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

Could you please describe the risks associated with Paltusotine?

"Paltusotine is considered safe by our team at Power, and it received a score of 3. This is due to the fact that this is a Phase 3 trial, meaning that not only is there some evidence of efficacy, but there have also been multiple rounds of data supporting safety."

Answered by AI

Could you please describe the previous Paltusotine clinical trials in detail?

"Paltusotine has 3 trials underway, 2 of which are Phase 3 studies. The vast majority of the 188 total clinical trial locations for Paltusotine are situated in Ciudad Autonoma de Buenos Aires and Pennsylvania."

Answered by AI

Are volunteers currently being sought for this experiment?

"That is accurate. The page on clinicaltrials.gov says that the clinical trial is currently looking for patients. The trial was first posted on 5/12/2021 and the most recent update was on 9/6/2022. The trial is enrolling 52 participants at 29 sites."

Answered by AI

Has this research been undertaken before?

"Paltusotine has been under medical scrutiny since 2019 when the first study, sponsored by Crinetics Pharmaceuticals Inc., was conducted. Since the initial study in 2019 which had 43 participants, Paltusotine received Phase 2 drug approval and there are now 3 live studies being conducted in 35 cities across 20 countries."

Answered by AI

Are there other facilities conducting this research in Canada?

"In 29 different locations across the country, medical institutions are recruiting patients for this study. A few examples include the Metabolic Research Institute in Boston, St. Joseph's Hospital & Medical Center - Barrow Neurological Institute in West Palm Beach, and Oregon Health & Science University in Rochester."

Answered by AI

How many participants are part of this experiment?

"In order to run this trial, 52 patients who fit the bill in terms of age, health, etc. are required. These individuals can come from different locations, such as the Metabolic Research Institute in Boston, Massachusetts or St. Joseph's Hospital & Medical Center - Barrow Neurological Institute in West Palm Beach, Florida."

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
2021. "A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04837040.
~15 spots leftby Apr 2025
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