Paltusotine for Acromegaly

Crinetics Study Site, Shijiazhuang, China
AcromegalyPaltusotine - Drug
All Sexes
What conditions do you have?

Study 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.

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 24 Weeks

24 Weeks
Change from baseline in IGF-1 to EOR
Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR
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)
Proportion of subjects with GH <1.0 ng/mL at Week 22
Proportion of subjects with IGF-1 <1.3 ng/mL at EOR

Trial Safety

Awards & Highlights

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

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

76 Total Participants · 2 Treatment Groups

Primary Treatment: Paltusotine · Has Placebo Group · Phase 3

Experimental Group · 1 Intervention: Paltusotine · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Crinetics Pharmaceuticals Inc.Lead Sponsor
9 Previous Clinical Trials
376 Total Patients Enrolled
4 Trials studying Acromegaly
161 Patients Enrolled for Acromegaly

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with acromegaly, but you either haven't started treatment yet, are not currently taking medication, or are willing to stop taking medication during the study screening.

Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Crinetics Study Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.