Trial Outcomes & Findings for Effects of Liothyronine on Energy Expenditure and Cardiovascular Function (NCT NCT03098433)

NCT ID: NCT03098433

Last Updated: 2021-03-26

Results Overview

Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: five hours
• Results posted on: 2021-03-26

Participant Flow

Participant milestones

Measure	Three Treatments in Random Order Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order. Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be analyzed therefore all participants are part of a single arm.
Overall Study STARTED	22
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure

Three Treatments in Random Order Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order. Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be analyzed therefore all participants are part of a single arm.

Overall Study Withdrawal by Subject

10

Baseline Characteristics

Effects of Liothyronine on Energy Expenditure and Cardiovascular Function

Baseline characteristics by cohort

Measure	Three Treatments in Random Order n=12 Participants Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order. Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be tracked.
Age, Continuous	27.7 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: five hours

Population: I participant did not undergo echocardiogram

Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration

Outcome measures

Measure	Three Treatments in Random Order n=11 Participants Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be tracked.
Cardiac Output Liothyronine	-3.7 millilitres Standard Deviation 8.8
Cardiac Output Levothyroxine	-1.4 millilitres Standard Deviation 6.5
Cardiac Output Placebo	1 millilitres Standard Deviation 6.2

SECONDARY outcome

Timeframe: five hours

Energy expenditure measured by Whole-Room Indirect Calorimeter, Difference in energy Expenditure Pre- and Post- Drug Administration Kcal

Outcome measures

Measure	Three Treatments in Random Order n=12 Participants Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be tracked.
Energy Expenditure Placebo	-0.007 kcal Standard Deviation 0.062
Energy Expenditure Liothyronine	0.006 kcal Standard Deviation 0.067
Energy Expenditure Levothyroxine	-0.05 kcal Standard Deviation 0.058

Adverse Events

Three Treatments in Random Order

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Francesco S. Celi, MD, MHSc.

Virginia Commonwealth University

Phone: 804-828-9696

Email: francesco.celi@vcuhealth.org

Results disclosure agreements

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