Trial · NCT02196831

Tesamorelin Effects on Liver Fat and Histology in HIV

NCT02196831, Not applicable, Completed, Massachusetts General Hospital; results first posted 2020-01-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Tesamorelin Effects on Liver Fat and Histology in HIV. Trials, record NCT02196831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02196831

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Tesamorelin Effects on Liver Fat and Histology in HIV
NCT number: NCT02196831
Status: Completed
Phases: Not applicable
Enrollment: 61 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
Interventions: tesamorelin, Placebo
First posted: 2014-07-22
Last updated: 2020-01-27
Results first posted: 2020-01-13

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy	change between baseline and 12 months	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.
Secondary	Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score	change between baseline and 12 months	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.
Secondary	Change in Alanine Aminotransferase (ALT)	change from baseline to 12 months	change (value at 12 months minus value at baseline)
Secondary	Change in Aspartate Aminotransferase (AST)	change from baseline to 12 months	change (value at 12 months minus value at baseline)

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy	change between baseline and 12 months	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.	percent (hepatic fat fraction)	MEAN
SECONDARY	Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score	change between baseline and 12 months	all participants with available biopsy data from both baseline and 12 month visits	score on a scale, NAFLD activity score	MEAN
SECONDARY	Change in Alanine Aminotransferase (ALT)	change from baseline to 12 months	all participants with available data at both baseline and 12 month visits	units/liter (U/L)	MEAN
SECONDARY	Change in Aspartate Aminotransferase (AST)	change from baseline to 12 months	all participants with available data at both baseline and 12 month visits	units/liter (U/L)	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy	Tesamorelin	-4.7	Standard Deviation 6.6	percent (hepatic fat fraction)
Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy	Placebo	0.0	Standard Deviation 4.1	percent (hepatic fat fraction)
Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score	Tesamorelin	-0.16	Standard Deviation 1.34	score on a scale, NAFLD activity score
Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score	Placebo	0.13	Standard Deviation 1.03	score on a scale, NAFLD activity score
Change in Alanine Aminotransferase (ALT)	Tesamorelin	-2	Standard Deviation 11	units/liter (U/L)
Change in Alanine Aminotransferase (ALT)	Placebo	5	Standard Deviation 15	units/liter (U/L)
Change in Aspartate Aminotransferase (AST)	Tesamorelin	-2	Standard Deviation 11	units/liter (U/L)
Change in Aspartate Aminotransferase (AST)	Placebo	-2	Standard Deviation 4	units/liter (U/L)

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tesamorelin	30
Overall Study	STARTED	Placebo	30
Overall Study	Received Follow-up Imaging	Tesamorelin	26
Overall Study	Received Follow-up Imaging	Placebo	28
Overall Study	COMPLETED	Tesamorelin	21
Overall Study	COMPLETED	Placebo	26
Overall Study	NOT COMPLETED	Tesamorelin	9
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events120

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Tesamorelin (Double-blind Phase)	1	31
other	Abdominal pain	Gastrointestinal disorders	Placebo (Double-blind Phase)	2	30
other	Abdominal pain	Gastrointestinal disorders	Open Label Tesamorelin Arm	0	43
other	Alanine aminotransferase increased	Investigations	Tesamorelin (Double-blind Phase)	7	31
other	Alanine aminotransferase increased	Investigations	Placebo (Double-blind Phase)	5	30
other	Alanine aminotransferase increased	Investigations	Open Label Tesamorelin Arm	4	43
other	Alkaline phosphatase increased	Investigations	Tesamorelin (Double-blind Phase)	3	31
other	Alkaline phosphatase increased	Investigations	Placebo (Double-blind Phase)	0	30
other	Alkaline phosphatase increased	Investigations	Open Label Tesamorelin Arm	2	43
other	Arthralgia	Musculoskeletal and connective tissue disorders	Tesamorelin (Double-blind Phase)	3	31

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tesamorelin (Double-blind Phase)	0	31
Total, all-cause mortality	Placebo (Double-blind Phase)	0	30
Total, all-cause mortality	Open Label Tesamorelin Arm	1	43
Total, other adverse events	Tesamorelin (Double-blind Phase)	29	31
Total, other adverse events	Placebo (Double-blind Phase)	29	30
Total, other adverse events	Open Label Tesamorelin Arm	35	43
Total, serious adverse events	Tesamorelin (Double-blind Phase)	4	31
Total, serious adverse events	Placebo (Double-blind Phase)	2	30
Total, serious adverse events	Open Label Tesamorelin Arm	3	43

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31611038	RESULT	PubMed
33125080	DERIVED	PubMed
33852720	DERIVED	PubMed
34006921	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AI115711	Tesamorelin Effects on Liver Fat and Histology in HIV: A Collaborative U01 Grant	GRINSPOON, STEVEN K.; HADIGAN, COLLEEN M	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2015 to 2017

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02196831

GET https://conductscience.org/api/trials/v1/NCT02196831/events?page=2

API reference For AI assistants