Trial Outcomes & Findings for Tesamorelin Effects on Liver Fat and Histology in HIV (NCT NCT02196831)

NCT ID: NCT02196831

Last Updated: 2020-01-27

Results Overview

change (value at 12 months minus value at baseline). Hepatic fat fraction is a standardized measure used to describe the percent fat in the liver. As it is determined by spectroscopy, it is quantified by the area under the lipid peak, standardized to the total area under the (lipid peak + water peak). Using 1-H Magnetic resonance spectroscopy to quantify liver fat in this manner was first described by Longo R et al., Invest Radiol, 1993, 28(4):297-302.

Recruitment status

COMPLETED

Study phase

Target enrollment

61 participants

Primary outcome timeframe

change between baseline and 12 months

Results posted on

2020-01-27

Participant Flow

1 subject was randomized to tesamorelin but self-discontinued during the baseline visit, prior to receiving any study drug. This individual is included in baseline characteristics but is not counted as starting tesamorelin (hence the discrepancy between 61 total enrolled and the 30 in tesamorelin and 30 in placebo group shown in participant flow).

Participant milestones

Participant milestones
Measure	Tesamorelin tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. tesamorelin	Placebo placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. Placebo: inactive substance that looks like tesamorelin
Overall Study STARTED	30	30
Overall Study Received Follow-up Imaging	26	28
Overall Study COMPLETED	21	26
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tesamorelin Effects on Liver Fat and Histology in HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tesamorelin n=31 Participants tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. tesamorelin	Placebo n=30 Participants placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. Placebo: inactive substance that looks like tesamorelin	Total n=61 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 8 • n=5 Participants	54 years STANDARD_DEVIATION 7 • n=7 Participants	53 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · White (all ethnicities)	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black (all ethnicities)	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other (all ethnicities)	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Hepatic Fibrosis Stage Stage 0 (No Fibrosis)	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Hepatic Fibrosis Stage Stage 1 Fibrosis	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Hepatic Fibrosis Stage Stage 2 Fibrosis	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Hepatic Fibrosis Stage Stage 3 Fibrosis	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Hepatic Fibrosis Stage Data Not Available	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: change between baseline and 12 months

Population: These are participants who had magnetic resonance spectroscopy for hepatic fat fraction at 0 and 12 months. This is different from the primary analysis population reported in the manuscript.

Outcome measures

Outcome measures
Measure	Tesamorelin n=20 Participants tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. tesamorelin	Placebo n=25 Participants placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. Placebo: inactive substance that looks like tesamorelin
Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy	-4.7 percent (hepatic fat fraction) Standard Deviation 6.6	0.0 percent (hepatic fat fraction) Standard Deviation 4.1

SECONDARY outcome

Timeframe: change between baseline and 12 months

Population: all participants with available biopsy data from both baseline and 12 month visits

change (value at 12 months minus value at baseline). The nonalcoholic fatty liver disease (NAFLD) activity score is a standardized histological quantification of NAFLD severity designed and validated by the Nonalcoholic Steatohepatitis Clinical Research Network (Kleiner DE et al., Hepatology, 2005, 41(6):1313-1321). The score is the sum of three semi-quantitative histological grades: 1. steatosis, graded from 0 \[\<5% liver fat\] to grade 3 \[\>66% liver fat\] 2. lobular inflammation, graded from 0 \[no foci of inflammation\] to 3 \[\>4 foci per 200x field\] 3. hepatocellular ballooning, graded from 0 \[no ballooning\] to 2 \[many cells/prominent ballooning\] The "total" NAFLD activity score, a sum of the three components below, ranges from 0 to 8, with a higher score generally representing greater severity of NAFLD/nonalcoholic steatohepatitis.

Outcome measures

Outcome measures
Measure	Tesamorelin n=19 Participants tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. tesamorelin	Placebo n=24 Participants placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. Placebo: inactive substance that looks like tesamorelin
Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score	-0.16 score on a scale, NAFLD activity score Standard Deviation 1.34	0.13 score on a scale, NAFLD activity score Standard Deviation 1.03

SECONDARY outcome

Timeframe: change from baseline to 12 months

Population: all participants with available data at both baseline and 12 month visits

change (value at 12 months minus value at baseline)

Outcome measures

Outcome measures
Measure	Tesamorelin n=21 Participants tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. tesamorelin	Placebo n=24 Participants placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. Placebo: inactive substance that looks like tesamorelin
Change in Alanine Aminotransferase (ALT)	-2 units/liter (U/L) Standard Deviation 11	5 units/liter (U/L) Standard Deviation 15

SECONDARY outcome

Timeframe: change from baseline to 12 months

Population: all participants with available data at both baseline and 12 month visits

change (value at 12 months minus value at baseline)

Outcome measures

Outcome measures
Measure	Tesamorelin n=20 Participants tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. tesamorelin	Placebo n=24 Participants placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. Placebo: inactive substance that looks like tesamorelin
Change in Aspartate Aminotransferase (AST)	-2 units/liter (U/L) Standard Deviation 11	-2 units/liter (U/L) Standard Deviation 4

Adverse Events

Tesamorelin (Double-blind Phase)

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo (Double-blind Phase)

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Open Label Tesamorelin Arm

Serious events: 3 serious events

Other events: 35 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Tesamorelin (Double-blind Phase) n=31 participants at risk tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. tesamorelin	Placebo (Double-blind Phase) n=30 participants at risk placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months. Placebo: inactive substance that looks like tesamorelin	Open Label Tesamorelin Arm n=43 participants at risk following the 12 month double-blind period, all subjects received open-label tesamorelin 2mg daily subcutaneously for 6 months.
Nervous system disorders Hemiplegia transient	3.2% 1/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Psychiatric disorders Anxiety Depression	0.00% 0/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	2.3% 1/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Hepatobiliary disorders Hepatic Hematoma	0.00% 0/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	3.3% 1/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Psychiatric disorders Suicide attempt	0.00% 0/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	3.3% 1/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Respiratory, thoracic and mediastinal disorders Pneumonia	3.2% 1/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	2.3% 1/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Infections and infestations Viral infection	3.2% 1/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Injury, poisoning and procedural complications Drug overdose	0.00% 0/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	2.3% 1/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Infections and infestations Soft tissue infection	0.00% 0/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	2.3% 1/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Infections and infestations Urosepsis	3.2% 1/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
Psychiatric disorders Active suicidal ideation	3.2% 1/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."
General disorders Death sudden	0.00% 0/31 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	0.00% 0/30 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."	2.3% 1/43 • Adverse events reported herein are from the double-blind (tesamorelin vs. placebo) phase of the study which was 12 months in length as well as the subsequent open-label phase 6 months in length. The primary analysis is from baseline to 12 months, during the "double-blind" phase. Adverse events from this phase are reported under the "Tesamorelin (Double-blind phase)" and "Placebo (Double-blind phase)" descriptors. 43 participants subsequently entered a 6 month open label phase during which all received tesamorelin. Data from this phase are not included in analysis, but Adverse Event data from the Open Label phase are included under the descriptor, "Open Label Tesamorelin Arm."

Other adverse events

Additional Information

Steven Grinspoon, MD

Massachusetts General Hospital

Phone: 617-724-9109

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place