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NCT05192382 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
A Phase 3 study of Acromegaly, sponsored by Crinetics Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 111
- Enrollment target
- 20
- Study locations
NCT05192382: Active Phase 3 study of Acromegaly, sponsored by Crinetics Pharmaceuticals.
NCT05192382 is a Phase 3 study of Acromegaly that is active but no longer recruiting, run by Crinetics Pharmaceuticals. The registered enrollment target is 111 participants, above the 93-participant average among 13 other Acromegaly trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05192382, a Phase 3 study of Acromegaly, is active but no longer recruiting, sponsored by Crinetics Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 111 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.
Primary Outcome
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Paltusotine
Study Locations (20)
Other
- Crinetics Study Site - Buenos Aires
- Crinetics Study Site - CABA
- Crinetics Study Site - CABA
- Crinetics Study Site - Córdoba
- Crinetics Study Site - Rio de Janeiro
- Crinetics Study Site - São Paulo
- Crinetics Study Site - São Paulo
- Crinetics Study Site - Sofia
Pennsylvania
- Crinetics Study Site - Philadelphia
- Crinetics Study Site - Pittsburgh
São Paulo
- Crinetics Study Site - Botucatu
- Crinetics Study Site - Campinas
Colorado
- Crinetics Study Site - Aurora
Massachusetts
- Crinetics Study Site - Boston
Ohio
- Crinetics Study Site - Columbus
Oregon
- Crinetics Study Site - Portland
Buenos Aires
- Crinetics Study Site - CABA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2021-12-17 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
What the registry record for NCT05192382 still lists
NCT05192382 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, above the 93-participant average among 13 other Acromegaly trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Acromegaly appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05192382 names 20 study sites across 11 states, led by Other, Pennsylvania, São Paulo.
Frequently Asked Questions
What is clinical trial NCT05192382 about?
NCT05192382 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)". A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.
What is the current status of trial NCT05192382?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2021-12-17. Estimated completion is 2028-01.
What conditions does trial NCT05192382 study?
This clinical trial studies the following conditions: Acromegaly.
What interventions are being tested in trial NCT05192382?
The interventions under investigation include: Placebo (DRUG), Paltusotine (DRUG).
Who is sponsoring clinical trial NCT05192382?
This trial is sponsored by Crinetics Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05192382 being conducted?
This trial has 20 study locations across Colorado, Massachusetts, Ohio, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acromegaly
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05192382's enrollment target sits among peer trials
111 3rd of 13 higher than 11 of 13 other Acromegaly trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acromegaly trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
RECRUITING · Phase 3
-
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
ACTIVE NOT RECRUITING · Phase 3
-
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
COMPLETED · Phase 3
-
ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
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-
Diet in the Management of Acromegaly
RECRUITING · NA
-
Study of MAR002 in Healthy Men
RECRUITING · Phase 1
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