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NCT05361668 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
A Phase 2 study, sponsored by Crinetics Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT05361668: Completed Phase 2 study, sponsored by Crinetics Pharmaceuticals.
NCT05361668 is a Phase 2 study that has completed, run by Crinetics Pharmaceuticals. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05361668, a Phase 2 study, has completed, sponsored by Crinetics Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.
Primary Outcome
Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose). In addition to all-cause mortality, deaths were categorized by primary cause (e.g., cardiovascular) based on medical adjudication. Events were coded using MedDRA and summarized by treatment group, system organ
Interventions
- DRUG Randomized: 40 mg Paltusotine
- DRUG Randomized: 80 mg Paltusotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-04-22 |
| Est. Completion | 2026-02-24 |
| Phase | Phase 2 |
What the finished NCT05361668 record still lists
NCT05361668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Randomized: 40 mg Paltusotine is the first listed.
NCT05361668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05361668 about?
NCT05361668 is a clinical study titled "Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome". The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.
What is the current status of trial NCT05361668?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2022-04-22. Estimated completion is 2026-02-24.
What interventions are being tested in trial NCT05361668?
The interventions under investigation include: Randomized: 40 mg Paltusotine (DRUG), Randomized: 80 mg Paltusotine (DRUG).
Who is sponsoring clinical trial NCT05361668?
This trial is sponsored by Crinetics Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05361668's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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