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Study · Randomized controlled trial · n = 61 · 2019

6 results

Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.

Stanley TL, Fourman LT, Feldpausch MN, Purdy J, Zheng I, Pan CS, Aepfelbacher J, Buckless C, Tsao A, Kellogg A, Branch K, Lee H and 7 more

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Liu CY, Corey KE, Chung RT, Torriani M, Kleiner DE, Hadigan CM, Grinspoon SK

The lancet. HIV11 Oct 2019Cited by 66 (Europe PMC)

PMID31611038 (opens in a new tab)PMCIDPMC6981288 (opens in a new tab)DOI10.1016/s2352-3018(19)30338-8 (opens in a new tab)PepBankPUB-31611038
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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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In people with HIV and NAFLD, tesamorelin reduced hepatic fat fraction more than placebo over 12 months.

    In plain wordsIn people with HIV and fatty liver, tesamorelin lowered liver fat more than placebo did.

    Peptide
    Tesamorelin
    Outcome
    DecreaseHepatic fat fraction change at 12 months
    Study

    n = 61

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    2 mg once daily · 12 monthsAs given in this study (human).

    Measurements

    HFF absolute difference vs placebo
    −4.1%
    12 months
    HFF relative reduction from baseline
    −37%
    12 months

    Source sentences

    Summary
    Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of -4·1% (95% CI -7·6 to -0·7, p=0·018), corresponding to a -37% (95% CI -67 to -7, p=0·016) relative reduction from baseline.
    3 context sentences
    Summary · context
    The primary endpoint was change in HFF between baseline and 12 months.
    Summary · context
    This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA.
    Summary · context
    Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In people with HIV and NAFLD, more participants had a hepatic fat fraction below 5% after 12 months of tesamorelin than of placebo.

    In plain wordsIn people with HIV and fatty liver, more people on tesamorelin than on placebo reached a normal liver fat level after 12 months.

    Peptide
    Tesamorelin
    Outcome
    IncreaseProportion with hepatic fat fraction below 5% at 12 months
    Study

    n = 61

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    2 mg once daily · 12 monthsAs given in this study (human).

    Measurements

    Participants with HFF below 5%
    35%
    tesamorelin
    Participants with HFF below 5%
    4%
    placebo

    Source sentences

    Summary
    After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069).
    2 context sentences
    Summary · context
    This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA.
    Summary · context
    Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily.
  3. 03HumanRandomized controlled trialSafety outcome

    In people with HIV and NAFLD, changes in fasting glucose did not differ between tesamorelin and placebo at 12 months.

    In plain wordsIn people with HIV and fatty liver, tesamorelin did not change fasting blood sugar differently from placebo.

    Peptide
    Tesamorelin
    Outcome
    No significant changeFasting glucose at 12 months
    Study

    n = 61

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg once daily · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months
    2 context sentences
    Summary · context
    This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA.
    Summary · context
    Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily.
  4. 04HumanRandomized controlled trialSafety outcome

    In people with HIV and NAFLD, changes in glycated haemoglobin did not differ between tesamorelin and placebo at 12 months.

    In plain wordsIn people with HIV and fatty liver, tesamorelin did not change long-term blood sugar markers differently from placebo.

    Peptide
    Tesamorelin
    Outcome
    No significant changeGlycated haemoglobin at 12 months
    Study

    n = 61

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg once daily · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months.
    2 context sentences
    Summary · context
    This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA.
    Summary · context
    Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily.
  5. 05HumanRandomized controlled trialSafety outcome

    In people with HIV and NAFLD, tesamorelin caused more localised injection site complaints than placebo.

    In plain wordsIn people with HIV and fatty liver, injection site complaints were more common with tesamorelin than with placebo.

    Peptide
    Tesamorelin
    Outcome
    IncreaseLocalised injection site complaints
    Study

    n = 61

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2 mg once daily · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
    2 context sentences
    Summary · context
    This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA.
    Summary · context
    Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily.
  6. 06HumanRandomized controlled trialSafety outcome

    In people with HIV and NAFLD, none of the injection site complaints with tesamorelin were judged to be serious.

    In plain wordsIn people with HIV and fatty liver, none of the injection site complaints with tesamorelin were judged serious.

    Peptide
    Tesamorelin
    Outcome
    No significant changeSerious injection site complaints
    Study

    n = 61

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2 mg once daily · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    though none were judged to be serious.
    2 context sentences
    Summary · context
    This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA.
    Summary · context
    Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily.

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

Registered trials1

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

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

CompletedNot applicableResults postedNCT02196831

Tesamorelin Effects on Liver Fat and Histology in HIV

Massachusetts General Hospitaln = 611 Jul 2015 to 24 Jul 2019

Human Immunodeficiency Virus (HIV) · Nonalcoholic Fatty Liver Disease (NAFLD) · Nonalcoholic Steatohepatitis (NASH)

Trial pageClinicalTrials.govUpdated 27 Jan 2020

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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