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NCT05757193 · ClinicalTrials.gov registry record · Phase 1
Ketone Pharmacokinetic Study in HFrEF
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05757193: Completed Phase 1 study, sponsored by Duke University.
NCT05757193 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05757193, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single visit. Participants will be served a light breakfast with the study drink, a physical exam will be conducted, and the study team will obtain information about demographics and medical history. The study team will draw blood intravenously up to eight times over the course of the half-day visit.
Primary Outcome
The pH scale ranges from 0 to 14, with 7 being neutral. Each number on the pH scale represents a ten-fold change in the acidity or basicity of a solution.
Interventions
- DIETARY_SUPPLEMENT DeltaG (250 mg/kg)
- DIETARY_SUPPLEMENT DeltaG (500 mg/kg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2024-01-11 |
| Phase | Phase 1 |
What the finished NCT05757193 record still lists
NCT05757193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which DeltaG (250 mg/kg) is the first listed.
NCT05757193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05757193 about?
NCT05757193 is a clinical study titled "Ketone Pharmacokinetic Study in HFrEF". The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single vis...
What is the current status of trial NCT05757193?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-06-02. Estimated completion is 2024-01-11.
What interventions are being tested in trial NCT05757193?
The interventions under investigation include: DeltaG (250 mg/kg) (DIETARY_SUPPLEMENT), DeltaG (500 mg/kg) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05757193?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05757193's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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