Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors.

Russo SC, Ockene MW, Arpante AK, Johnson JE, Lee H, Toribio M, Stanley TL, Hadigan CM, Grinspoon SK, Erlandson KM, Fourman LT

AIDS (London, England)20 Jun 2024Cited by 2 (Europe PMC)

PMID38905488PMCIDPMC11365754DOI10.1097/qad.0000000000003965PepBankPUB-38905488

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In people with HIV on integrase inhibitors, tesamorelin significantly reduced visceral fat versus placebo over 12 months.
In plain wordsIn people with HIV on integrase inhibitors, tesamorelin reduced visceral fat compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseVisceral fat change
Study
n = 31
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once daily · 12 monthsAs given in this study (human).
Measurements
Median change in visceral fat
−25 cm 2
tesamorelin
Median change in visceral fat
14 cm 2
placebo
Source sentences
Summary
Tesamorelin led to significant declines in visceral fat (median [interquartile range]: -25 [-93, -2] vs. 14 [3, 41] cm 2 , P = 0.001), hepatic fat (-4.2% [-12.3%, -2.7%] vs. -0.5% [-3.9%, 2.7%], P = 0.01), and trunk-to-appendicular fat ratio (-0.1 [-0.3, 0.0] vs. 0.0 [-0.1, 0.1], P = 0.03).
2 context sentences(design, population, supporting numbers)
Summary · context
We leveraged a randomized double-blind trial of 61 PWH and metabolic dysfunction-associated steatotic liver disease to evaluate the efficacy and safety of tesamorelin 2 mg once daily vs. identical placebo among participants on INSTI-based regimens at baseline.
Summary · context
Among 38 participants on INSTI-based regimens at baseline, 15 individuals on tesamorelin and 16 individuals on placebo completed the 12-month study.
Report a problemFND-3890548801
02HumanRandomized controlled trialEfficacy outcome
In people with HIV on integrase inhibitors and fatty liver disease, tesamorelin significantly reduced hepatic fat versus placebo over 12 months.
In plain wordsIn people with HIV on integrase inhibitors, tesamorelin reduced liver fat compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseHepatic fat change
Study
n = 31
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
2 mg once daily · 12 monthsAs given in this study (human).
Measurements
Median change in hepatic fat
−4.2%
tesamorelin
Median change in hepatic fat
−0.5%
placebo
Source sentences
Summary
Tesamorelin led to significant declines in visceral fat (median [interquartile range]: -25 [-93, -2] vs. 14 [3, 41] cm 2 , P = 0.001), hepatic fat (-4.2% [-12.3%, -2.7%] vs. -0.5% [-3.9%, 2.7%], P = 0.01), and trunk-to-appendicular fat ratio (-0.1 [-0.3, 0.0] vs. 0.0 [-0.1, 0.1], P = 0.03).
2 context sentences(design, population, supporting numbers)
Summary · context
We leveraged a randomized double-blind trial of 61 PWH and metabolic dysfunction-associated steatotic liver disease to evaluate the efficacy and safety of tesamorelin 2 mg once daily vs. identical placebo among participants on INSTI-based regimens at baseline.
Summary · context
Among 38 participants on INSTI-based regimens at baseline, 15 individuals on tesamorelin and 16 individuals on placebo completed the 12-month study.
Report a problemFND-3890548802
03HumanRandomized controlled trialEfficacy outcome
In people with HIV on integrase inhibitors, tesamorelin significantly reduced the trunk-to-appendicular fat ratio versus placebo over 12 months.
In plain wordsIn people with HIV on integrase inhibitors, tesamorelin lowered the ratio of trunk fat to limb fat compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseTrunk-to-appendicular fat ratio change
Study
n = 31
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once daily · 12 monthsAs given in this study (human).
Measurements
Median change in trunk-to-appendicular fat ratio
−0.1 ratio
tesamorelin
Source sentences
Summary
Tesamorelin led to significant declines in visceral fat (median [interquartile range]: -25 [-93, -2] vs. 14 [3, 41] cm 2 , P = 0.001), hepatic fat (-4.2% [-12.3%, -2.7%] vs. -0.5% [-3.9%, 2.7%], P = 0.01), and trunk-to-appendicular fat ratio (-0.1 [-0.3, 0.0] vs. 0.0 [-0.1, 0.1], P = 0.03).
2 context sentences(design, population, supporting numbers)
Summary · context
We leveraged a randomized double-blind trial of 61 PWH and metabolic dysfunction-associated steatotic liver disease to evaluate the efficacy and safety of tesamorelin 2 mg once daily vs. identical placebo among participants on INSTI-based regimens at baseline.
Summary · context
Among 38 participants on INSTI-based regimens at baseline, 15 individuals on tesamorelin and 16 individuals on placebo completed the 12-month study.
Report a problemFND-3890548803
04HumanRandomized controlled trialSafety outcome
In people with HIV on integrase inhibitors, tesamorelin was well tolerated with a similar frequency of adverse events as placebo.
In plain wordsIn people with HIV on integrase inhibitors, tesamorelin was well tolerated, with adverse events about as common as with placebo.
Peptide
Tesamorelin
Outcome
No significant changeAdverse event frequency
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2 mg once daily · 12 monthsAs given in this study (human).
Source sentences
Summary
Tesamorelin was well tolerated with a similar frequency of adverse events, including hyperglycemia, between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
We leveraged a randomized double-blind trial of 61 PWH and metabolic dysfunction-associated steatotic liver disease to evaluate the efficacy and safety of tesamorelin 2 mg once daily vs. identical placebo among participants on INSTI-based regimens at baseline.
Summary · context
Among 38 participants on INSTI-based regimens at baseline, 15 individuals on tesamorelin and 16 individuals on placebo completed the 12-month study.
Report a problemFND-3890548804
05HumanRandomized controlled trialSafety outcome
In people with HIV on integrase inhibitors, hyperglycemia occurred with similar frequency with tesamorelin and placebo.
In plain wordsIn people with HIV on integrase inhibitors, high blood sugar was about as common with tesamorelin as with placebo.
Peptide
Tesamorelin
Outcome
No significant changeHyperglycemia frequency
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once daily · 12 monthsAs given in this study (human).
Source sentences
Summary
Tesamorelin was well tolerated with a similar frequency of adverse events, including hyperglycemia, between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
We leveraged a randomized double-blind trial of 61 PWH and metabolic dysfunction-associated steatotic liver disease to evaluate the efficacy and safety of tesamorelin 2 mg once daily vs. identical placebo among participants on INSTI-based regimens at baseline.
Summary · context
Among 38 participants on INSTI-based regimens at baseline, 15 individuals on tesamorelin and 16 individuals on placebo completed the 12-month study.
Report a problemFND-3890548805

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
9 Oct 2026, 19:08 UTC
Study results updated
Version 1
9 Oct 2026, 03:13 UTC
First added · source update from Europe PMC

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