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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16, week 312
Awards & highlights

Study Summary

This trial is designed to see if a drug called paltusotine is safe and effective at treating acromegaly, a condition characterized by too much growth hormone.

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.Check my eligibility
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.See study design
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
Select...
I am not pregnant or breastfeeding, and I am either unable to have children, past menopause, or using birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16, week 312
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16, week 312 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Secondary outcome measures
Change in growth hormone (GH) level
Change in insulin-like growth factor-1 (IGF-1) level

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

Find a Location

Who is running the clinical trial?

Crinetics Pharmaceuticals Inc.Lead Sponsor
11 Previous Clinical Trials
568 Total Patients Enrolled
4 Trials studying Acromegaly
229 Patients Enrolled for Acromegaly

Media Library

Paltusotine (Somatostatin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04261712 — Phase 2
Acromegaly Research Study Groups: Paltusotine
Acromegaly Clinical Trial 2023: Paltusotine Highlights & Side Effects. Trial Name: NCT04261712 — Phase 2
Paltusotine (Somatostatin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04261712 — Phase 2

Frequently Asked Questions

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

What is the current size of the participant cohort for this research?

"This study is no longer taking on new participants. It was first introduced in January 2019, and the most recent updates were posted October 5th 2022. For those looking for other studies, 14 trials are available to individuals with acromegaly while 3 clinical trials are recruiting patients suffering from Paltusotine."

Answered by AI

Is the age eligibility for this experiment restricted to adults only?

"As per the eligibility criteria outlined in this clinical trial, participants must be aged 18 years or older and no more than 75."

Answered by AI

Has Paltusotine obtained regulatory sanction from the FDA?

"As Paltusotine is currently in a Phase 2 trial, our team at Power has determined its safety to be a 2 on the scale. This result was based off of existing evidence suggesting safe usage but little-to-no efficacy data."

Answered by AI

Are there any institutions administering this trial within the locality?

"Crinetics Study Site in Boston, Massachusetts, Northwestern University in Portland, Oregon and Ohio State University in Columbus, Ohio are three of the 15 sites accepting patients for this medical trial."

Answered by AI

Is enrollment still open for this scientific research?

"This research project is not currently recruiting any more volunteers. It was initially posted in the first month of 2019, with its most recent edit performed on October 5th 2022. However, 14 different studies are actively enrolling participants who suffer from acromegaly and 3 trials for Paltusotine have open recruitment spots at present."

Answered by AI

Could you provide a summary of the research conducted utilizing Paltusotine?

"Presently, there are three ongoing trials for Paltusotine in Phase 3 of development. Concentrated primarily in Barcelona and Pennsylvania, 188 sites across the globe have studies underway with this medication."

Answered by AI

Is this research venture an unprecedented endeavor?

"Since its initial research in 2019, Paltusotine has undergone significant clinical trials; the first of which was sponsored by Crinetics Pharmaceuticals Inc. and included 43 participants. Following this successful Phase 2 trial, 3 live studies are now taking place across 35 cities and 20 nations."

Answered by AI

Can I partake in this clinical investigation?

"To be eligible to join this medical trial, individuals must suffer from acromegaly and fall within the bracket of 18-75 years old. A total quota of 43 patients needs to be filled for the experiment."

Answered by AI

Who else is applying?

What site did they apply to?
Ohio State University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

The existing treatment options for acromegaly are unsatisfactory in many ways and I am eager to explore emerging therapies.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)
2019. "A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04261712.
~18 spots leftby Mar 2028
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