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NCT04837040 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
A Phase 3 study of Acromegaly, sponsored by Crinetics Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
- 20
- Study locations
NCT04837040: Active Phase 3 study of Acromegaly, sponsored by Crinetics Pharmaceuticals.
NCT04837040 is a Phase 3 study of Acromegaly that is active but no longer recruiting, run by Crinetics Pharmaceuticals. The registered enrollment target is 58 participants, below the 97-participant average among 13 other Acromegaly trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04837040, 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
- 58 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
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 (weeks 34 and 36).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Paltusotine
Study Locations (20)
Other
- Crinetics Study Site - Córdoba
- Crinetics Study Site - Ghent
- Crinetics Study Site - Rio de Janeiro
- Crinetics Study Site - Rio de Janeiro
- Crinetics Study Site - Sofia
- Crinetics Study Site - Bron
- Crinetics Study Site - Pessac
- Crinetics Study Site - Budapest
California
- Crinetics Study Site - Los Angeles
- Crinetics Study Site - Torrance
Pennsylvania
- Crinetics Study Site - Philadelphia
- Crinetics Study Site - Pittsburgh
Buenos Aires
- Crinetics Study Site - CABA
- Crinetics Study Site - Ciudad Autonoma de Buenos Aire
Maryland
- Crinetics Study Site - Baltimore
Massachusetts
- Crinetics Study Site - Boston
Tennessee
- Crinetics Study Site - Nashville
Ceará
- Crinetics Study Site - Fortaleza
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2021-05-12 |
| Est. Completion | 2027-06 |
| Phase | Phase 3 |
What the registry record for NCT04837040 still lists
NCT04837040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 97-participant average among 13 other Acromegaly trials with a reported enrollment target (40% lower).
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.
NCT04837040 names 20 study sites across 10 states, led by Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04837040 about?
NCT04837040 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly". A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
What is the current status of trial NCT04837040?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2021-05-12. Estimated completion is 2027-06.
What conditions does trial NCT04837040 study?
This clinical trial studies the following conditions: Acromegaly.
What interventions are being tested in trial NCT04837040?
The interventions under investigation include: Placebo (DRUG), Paltusotine (DRUG).
Who is sponsoring clinical trial NCT04837040?
This trial is sponsored by Crinetics Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04837040 being conducted?
This trial has 20 study locations across California, Maryland, Massachusetts, Pennsylvania, Tennessee. 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 NCT04837040's enrollment target sits among peer trials
58 9th of 13 higher than 5 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 (PATHFNDR-2)
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
RECRUITING · Phase 2
-
Diet in the Management of Acromegaly
RECRUITING · NA
-
Study of MAR002 in Healthy Men
RECRUITING · Phase 1
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