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NCT03292653 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure
A Phase 2 study, sponsored by Lexicon Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT03292653: Clinical Trial Phase 2 study, sponsored by Lexicon Pharmaceuticals.
NCT03292653 is a Phase 2 study that was terminated before completion, run by Lexicon Pharmaceuticals. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03292653, a Phase 2 study, was terminated before completion, sponsored by Lexicon Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Primary Objectives: * Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart failure, compared to placebo. Secondary Objectives: * Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
Primary Outcome
AE: is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participants at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitali
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2019-08-17 |
| Phase | Phase 2 |
Why NCT03292653 stopped before completion
NCT03292653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03292653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03292653 about?
NCT03292653 is a clinical study titled "Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure". Primary Objectives: * Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart fail...
What is the current status of trial NCT03292653?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2017-12-04. Estimated completion is 2019-08-17.
What interventions are being tested in trial NCT03292653?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT03292653?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03292653's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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