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Study · Observational study · 2017

3 results

Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV.

Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK

AIDS (London, England)1 Oct 2017Cited by 10 (Europe PMC)

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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanObservational studyEfficacy outcome

    In HIV-infected patients with abdominal obesity and elevated baseline ALT or AST, visceral fat responders to tesamorelin had greater ALT reductions than non-responders over 26 weeks.

    In plain wordsIn people with HIV and extra belly fat, tesamorelin responders had a larger ALT liver enzyme drop than non-responders.

    Outcome
    DecreaseALT change at 26 weeks in VAT responders
    Study

    n: not reported in source

    Comparator
    VAT non-responders given tesamorelin
    Analysis
    Exploratory
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    ALT change, responders
    −8.9 U/l
    26 weeks
    ALT change, non-responders
    1.4 U/l
    26 weeks

    Source sentences

    Summary
    In study participants assigned to tesamorelin with baseline ALT or AST more than 30 U/l, VAT responders experienced greater reductions in ALT (-8.9 ± 22.6 vs. 1.4 ± 34.7 U/l, P = 0.004) and AST (-3.8 ± 12.9 vs. 0.4 ± 22.4 U/l, P = 0.04) compared with nonresponders over 26 weeks.
    2 context sentences
    Summary · context
    We utilized data from two multicenter Phase III trials of tesamorelin among 806 HIV-infected patients with abdominal obesity.
    Summary · context
    Within this group, we compared changes in ALT and AST in VAT responders vs. nonresponders after 26 weeks of treatment, and then assessed the effects of drug discontinuation on these endpoints over a subsequent 26-week period.
  2. 02HumanObservational studyEfficacy outcome

    In HIV-infected patients with abdominal obesity and elevated baseline ALT or AST, visceral fat responders to tesamorelin had greater AST reductions than non-responders over 26 weeks.

    In plain wordsIn people with HIV and extra belly fat, tesamorelin responders had a larger AST liver enzyme drop than non-responders.

    Outcome
    DecreaseAST change at 26 weeks in VAT responders
    Study

    n: not reported in source

    Comparator
    VAT non-responders given tesamorelin
    Analysis
    Exploratory
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    AST change, responders
    −3.8 U/l
    26 weeks
    AST change, non-responders
    0.4 U/l
    26 weeks

    Source sentences

    Summary
    In study participants assigned to tesamorelin with baseline ALT or AST more than 30 U/l, VAT responders experienced greater reductions in ALT (-8.9 ± 22.6 vs. 1.4 ± 34.7 U/l, P = 0.004) and AST (-3.8 ± 12.9 vs. 0.4 ± 22.4 U/l, P = 0.04) compared with nonresponders over 26 weeks.
    2 context sentences
    Summary · context
    We utilized data from two multicenter Phase III trials of tesamorelin among 806 HIV-infected patients with abdominal obesity.
    Summary · context
    Within this group, we compared changes in ALT and AST in VAT responders vs. nonresponders after 26 weeks of treatment, and then assessed the effects of drug discontinuation on these endpoints over a subsequent 26-week period.
  3. 03HumanObservational studyEfficacy outcome

    In VAT responders to tesamorelin, the improvement in liver enzymes persisted over 52 weeks, even in those switched to placebo despite partial reaccumulation of VAT.

    In plain wordsIn people with HIV whose belly fat fell on tesamorelin, liver enzyme improvement lasted to week 52, even after switching to placebo.

    Outcome
    DecreasePersistence of liver enzyme improvement at 52 weeks after switch to placebo
    Study

    n: not reported in source

    Comparator
    VAT non-responders given tesamorelin
    Analysis
    Exploratory
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    This improvement among VAT responders persisted over 52 weeks even in those switched to placebo despite a partial reaccumulation of VAT.
    2 context sentences
    Summary · context
    We utilized data from two multicenter Phase III trials of tesamorelin among 806 HIV-infected patients with abdominal obesity.
    Summary · context
    Within this group, we compared changes in ALT and AST in VAT responders vs. nonresponders after 26 weeks of treatment, and then assessed the effects of drug discontinuation on these endpoints over a subsequent 26-week period.

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

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00608023

TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

Theratechnologiesn = 263Aug 2007 to Oct 2008

Lipodystrophy · HIV Infections

Trial pageClinicalTrials.govUpdated 30 Sept 2022
CompletedPhase 3NCT00123253

TH9507 in Patients With HIV-Associated Lipodystrophy

Theratechnologiesn = 412Jun 2005 to Apr 2007

HIV Infections · Lipodystrophy

Trial pageClinicalTrials.govUpdated 27 Nov 2013

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.

  1. Version 2Current

    9 Oct 2026, 19:08 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:13 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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