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NCT04004325 · ClinicalTrials.gov registry record · Phase 1
A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis
A Phase 1 study, sponsored by Forma Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT04004325: Clinical Trial Phase 1 study, sponsored by Forma Therapeutics.
NCT04004325 is a Phase 1 study that was terminated before completion, run by Forma Therapeutics. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04004325, a Phase 1 study, was terminated before completion, sponsored by Forma Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts.
Primary Outcome
TEAEs were defined as an adverse events (AEs) with an onset that occurred after receiving the first dose of the study drug (AE start date greater than or equal to \[\>=\] first dose date) and within 30 days after receiving the last dose of the study drug (AE start date - last dose date less than or equal to \[\<=\] 30). Number of participants with TEAEs are reported.
Interventions
- DRUG FT-4101
- DRUG FT-4101 placebo
- OTHER Deuterated Water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-05-17 |
| Est. Completion | 2020-01-20 |
| Phase | Phase 1 |
Why NCT04004325 stopped before completion
NCT04004325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which FT-4101 is the first listed.
NCT04004325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04004325 about?
NCT04004325 is a clinical study titled "A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis". This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts.
What is the current status of trial NCT04004325?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2019-05-17. Estimated completion is 2020-01-20.
What interventions are being tested in trial NCT04004325?
The interventions under investigation include: FT-4101 (DRUG), FT-4101 placebo (DRUG), Deuterated Water (OTHER).
Who is sponsoring clinical trial NCT04004325?
This trial is sponsored by Forma Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04004325's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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