CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
DeltaG (250 mg/kg) +1 moredietary
Likely dose
DeltaG (250 mg/kg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05757193
NCT05757193Phase 1Completed
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Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction

Duke University·interventional·Posted Mar 7, 2023·Updated Dec 27, 2024

In Brief

A Phase 1 clinical trial evaluating DeltaG (250 mg/kg) and DeltaG (500 mg/kg) for Heart Failure With Reduced Ejection Fraction. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure With Reduced Ejection Fraction
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), American Heart Association

Timeline

Phase 1CompletedFinished
202420252026
First PostedMar 7, 2023
Enrollment StartJun 2, 2023
Primary CompletionJan 11, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.3 years ago

Interventions

DeltaG (250 mg/kg)dietary

250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate

DeltaG (500 mg/kg)dietary

500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate