Trial Outcomes & Findings for LIPIDS-P Trial Phase I/II Trial (NCT NCT03405870)

NCT ID: NCT03405870

Last Updated: 2025-08-11

Results Overview

Change in total cholesterol (48 hour - enrollment value) of 0 to +5 mg/dL

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2025-08-11

Participant Flow

The study has a Phase II design. After evaluating for DLT, 49 enrolled (2 withdrawals) with 47 patients completing the Phase II study to either Smoflipid (intervention) or control. Only Phase II data are reported here.

Participant milestones

Measure	Phase II - 1.2 g/kg Smoflipid These patients recieved 1.2 g/kg of smoflipid.	Phase II - 1.4 g/kg Smoflipid These patients recieved 1.4 g/kg of smoflipid.	Phase II - 1.6 g/kg Smoflipid These patients recieved 1.6 g/kg of smoflipid.	Phase II - Control Active Control	Phase I - 1.0 g/kg Smoflipid These patients recieved 1.0 g/kg of smoflipid.	Phase I - 1.2 g/kg Smoflipid These patients recieved 1.2 g/kg of smoflipid.	Phase I - 1.4 g/kg Smoflipid These patients recieved 1.4 g/kg of smoflipid.	Phase I - 1.6 g/kg Smoflipid These patients recieved 1.6 g/kg of smoflipid.
Overall Study STARTED	11	4	10	24	2	2	3	3
Overall Study COMPLETED	10	4	9	24	2	2	2	3
Overall Study NOT COMPLETED	1	0	1	0	0	0	1	0

Reasons for withdrawal

Measure	Phase II - 1.2 g/kg Smoflipid These patients recieved 1.2 g/kg of smoflipid.	Phase II - 1.4 g/kg Smoflipid These patients recieved 1.4 g/kg of smoflipid.	Phase II - 1.6 g/kg Smoflipid These patients recieved 1.6 g/kg of smoflipid.	Phase II - Control Active Control	Phase I - 1.0 g/kg Smoflipid These patients recieved 1.0 g/kg of smoflipid.	Phase I - 1.2 g/kg Smoflipid These patients recieved 1.2 g/kg of smoflipid.	Phase I - 1.4 g/kg Smoflipid These patients recieved 1.4 g/kg of smoflipid.	Phase I - 1.6 g/kg Smoflipid These patients recieved 1.6 g/kg of smoflipid.
Overall Study Withdrawal	1	0	1	0	0	0	1	0

Baseline Characteristics

LIPIDS-P Trial Phase I/II Trial

Baseline characteristics by cohort

Measure	Phase II - 1.2 g/kg Smoflipid n=10 Participants Infusion of drug (Smoflipid) will occur over a 16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.4 g/kg Smoflipid n=4 Participants Infusion of drug (Smoflipid) will occur over a 16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.6 g/kg Smoflipid n=9 Participants Infusion of drug (Smoflipid) will occur over a 16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - Control n=24 Participants Patients will be followed as active controls, cholesterol levels and labs for lipid measures will be drawn.	Phase I - 1.0 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.2 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.4 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.6 g/kg Smoflipid n=3 Participants Infusion of drug (Smoflipid) will occur over a 16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Total n=56 Participants Total of all reporting groups
Age, Customized Age, y	71 years n=5 Participants	63 years n=7 Participants	67 years n=5 Participants	68 years n=4 Participants	66 years n=21 Participants	53 years n=10 Participants	53 years n=115 Participants	59 years n=24 Participants	65 years n=42 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants	24 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	32 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	26 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=24 Participants	28 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Region of Enrollment United States	10 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants	24 participants n=4 Participants	2 participants n=21 Participants	2 participants n=10 Participants	2 participants n=115 Participants	3 participants n=24 Participants	56 participants n=42 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Phase II participants were analyzed for the primary outcome of change in total cholesterol at 48 hours (47 patients) at doses of 1.2, 1.4 and 1.6 g/kg. Phase I participants were also analyzed for this outcome, although it was not the primary outcome for this phase (which was maximum tolerated dose).

Change in total cholesterol (48 hour - enrollment value) of 0 to +5 mg/dL

Outcome measures

Measure	Phase II - 1.2 g/kg Smoflipid n=10 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.4 g/kg Smoflipid n=4 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.6 g/kg Smoflipid n=9 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - Control n=24 Participants No drug, patients will be followed as active controls	Phase I - 1.0 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.2 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.4 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.6 g/kg Smoflipid n=3 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion
Phase II - Primary Outcome - Change in Total Cholesterol (48 Hours - Enrollment)	9 mg/dL Standard Deviation 17	-10 mg/dL Standard Deviation 29	4 mg/dL Standard Deviation 21	2 mg/dL Standard Deviation 18	-12 mg/dL Standard Deviation 23	16 mg/dL Standard Deviation 1	-9 mg/dL Standard Deviation 10	-18 mg/dL Standard Deviation 9

PRIMARY outcome

Timeframe: First 48 hours

Population: Only Phase I trial patients were analyzed for this component of the study.

Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment to test the maximum tolerated dose of study drug. The maximum tolerated dose was defined by patients exhibiting specific dose-related toxicities from administration of escalating doses of the study drug. Of 9 patients, adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of these were classified as dose limiting or serious.

Outcome measures

Measure	Phase II - 1.2 g/kg Smoflipid Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.4 g/kg Smoflipid Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.6 g/kg Smoflipid Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - Control No drug, patients will be followed as active controls	Phase I - 1.0 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.2 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.4 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.6 g/kg Smoflipid n=3 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion
Phase I - Primary Outcome - Maximum Tolerated Dose/Participants Experiencing Dose Related Toxicity	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours

Population: Phase I and II participants were analyzed for this secondary outcome of change in SOFA score from 0 to 48 hours.

Sequential Organ Failure Assessment (SOFA) Score, this is a numerical score ranging from 0 to 24. A Higher SOFA score represents worsening organ dysfunction is correlated with higher rate of mortality. We measured the change over 48 hours.

Outcome measures

Measure	Phase II - 1.2 g/kg Smoflipid n=10 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.4 g/kg Smoflipid n=4 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.6 g/kg Smoflipid n=9 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - Control n=24 Participants No drug, patients will be followed as active controls	Phase I - 1.0 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.2 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.4 g/kg Smoflipid n=2 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.6 g/kg Smoflipid n=3 Participants Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion
Phase II - Secondary Outcome - Organ Dysfunction	1 score on a scale Interval -2.0 to 1.0	0 score on a scale Interval -5.0 to 0.0	-2 score on a scale Interval -3.0 to -2.0	-2 score on a scale Interval -4.0 to -1.0	4 score on a scale Interval 3.0 to 4.0	-5 score on a scale Interval -6.0 to -4.0	-2 score on a scale Interval -3.0 to 0.0	0 score on a scale Interval -2.0 to 2.0

Adverse Events

Phase II - 1.2 g/kg Smoflipid

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Phase II - 1.4 g/kg Smoflipid

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase II - 1.6 g/kg Smoflipid

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Phase II - Control

Serious events: 8 serious events

Other events: 8 other events

Deaths: 7 deaths

Phase I - 1.0 g/kg Smoflipid

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Phase I - 1.2 g/kg Smoflipid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase I - 1.4 g/kg Smoflipid

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Phase I - 1.6 g/kg Smoflipid

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Measure	Phase II - 1.2 g/kg Smoflipid n=10 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.4 g/kg Smoflipid n=4 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.6 g/kg Smoflipid n=9 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - Control n=24 participants at risk Active Control, no drug	Phase I - 1.0 g/kg Smoflipid n=2 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.2 g/kg Smoflipid n=2 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.4 g/kg Smoflipid n=2 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.6 g/kg Smoflipid n=3 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion
General disorders Death	10.0% 1/10 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	75.0% 3/4 • Number of events 3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	29.2% 7/24 • Number of events 7 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	66.7% 2/3 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
Respiratory, thoracic and mediastinal disorders Intubation	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	12.5% 3/24 • Number of events 3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	100.0% 2/2 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	33.3% 1/3 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Hospital Readmission	10.0% 1/10 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	11.1% 1/9 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Vasopressor Support	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	4.2% 1/24 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
Cardiac disorders Cardiac Arrest	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	4.2% 1/24 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.

Other adverse events

Measure	Phase II - 1.2 g/kg Smoflipid n=10 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.4 g/kg Smoflipid n=4 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - 1.6 g/kg Smoflipid n=9 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase II - Control n=24 participants at risk Active Control, no drug	Phase I - 1.0 g/kg Smoflipid n=2 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.2 g/kg Smoflipid n=2 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.4 g/kg Smoflipid n=2 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion	Phase I - 1.6 g/kg Smoflipid n=3 participants at risk Infusion of drug (Smoflipid) will occur over a 10-16.5 hour period given once per day for the first two days of study enrollment. Smoflipid: Administration of lipid injectable emulsion
General disorders Hyperglycemia	10.0% 1/10 • Number of events 10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	33.3% 1/3 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Elevated triglycerides	20.0% 2/10 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	22.2% 2/9 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	12.5% 3/24 • Number of events 4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	33.3% 1/3 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Elevated Total Bili	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	4.2% 1/24 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Thrombocytopenia	20.0% 2/10 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	22.2% 2/9 • Number of events 3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	25.0% 6/24 • Number of events 9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Decreased phosphorus	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Line infiltration	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	22.2% 2/9 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	33.3% 1/3 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Elevated creatinine	20.0% 2/10 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	25.0% 1/4 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	11.1% 1/9 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Elevated LFT's	10.0% 1/10 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Hypoglycemia	10.0% 1/10 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Elevated ALT	10.0% 1/10 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	11.1% 1/9 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	4.2% 1/24 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
Hepatobiliary disorders Elevated AST	10.0% 1/10 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/9 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	4.2% 1/24 • Number of events 2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	50.0% 1/2 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Itch	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	11.1% 1/9 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Elevated INR	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	11.1% 1/9 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	33.3% 1/3 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.
General disorders Nausea and Vomiting	0.00% 0/10 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/4 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	11.1% 1/9 • Number of events 1 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/24 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/2 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.	0.00% 0/3 • Adverse event data were collected from enrollment through 28 days after enrollment. Adverse events were any unfavorable and unintended sign, symptom, or disease temporally associated with the use of Smoflipid in this study. Adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria. None of the these were classified as dose limiting or serious.

Additional Information

Dr. Faheem Guirgis, MD

University of Florida College of Medicine

Phone: 352-733-1469

Email: fguirgis@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place