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Study · Observational study · n = 402 · 2012

5 results

Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin.

Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America10 Apr 2012Cited by 23 (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 study5

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

  1. 01HumanObservational studyEfficacy outcome

    In HIV-infected patients with abdominal fat treated with tesamorelin, those with at least 8% VAT reduction had a greater fall in triglycerides than nonresponders.

    In plain wordsOn tesamorelin, HIV-infected patients whose belly fat fell 8% or more had a bigger triglyceride drop than those whose belly fat fell less.

    Outcome
    DecreaseTriglyceride change in VAT responders vs nonresponders
    Study

    n = 402

    Comparator
    Tesamorelin nonresponders
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    Dose not stated · 26 to 52 weeksAs given in this study (human).

    Measurements

    Triglyceride change at 26 weeks
    −0.6 mmol/L
    responders
    Triglyceride change at 26 weeks
    −0.1 mmol/L
    nonresponders
    Triglyceride change at 52 weeks
    −0.8 mmol/L
    responders

    Source sentences

    Summary
    Compared with tesamorelin nonresponders, responders experienced greater mean (±SD) reduction in triglyceride levels (26 weeks: -0.6 ± 1.7 mmol/L vs -0.1 ± 1.2 mmol/L [P = .005]; 52 weeks: -0.8 ± 1.8 mmol/L vs 0.0 ± 1.1 mmol/L [P = .003]
    2 context sentences
    Summary · context
    In 2 phase III, randomized, double-blind studies, men and women with HIV-associated abdominal fat accumulation were randomly assigned (ratio, 2:1) to receive tesamorelin or placebo for 26 weeks.
    Summary · context
    In per-protocol analysis of 402 subjects initially randomly assigned to receive tesamorelin, those with ≥8% reduction in VAT were defined a priori as responders per the statistical analysis plan.
  2. 02HumanObservational studyEfficacy outcome

    In HIV-infected patients treated with tesamorelin, VAT responders had attenuated rises in fasting glucose compared with nonresponders.

    In plain wordsOn tesamorelin, HIV-infected patients whose belly fat fell 8% or more had smaller fasting blood sugar rises than those whose belly fat fell less.

    Outcome
    DecreaseFasting glucose change in VAT responders vs nonresponders
    Study

    n = 402

    Comparator
    Tesamorelin nonresponders
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 26 to 52 weeksAs given in this study (human).

    Measurements

    Fasting glucose change at 52 weeks
    −1 mg/dL
    responders
    Fasting glucose change at 52 weeks
    8 mg/dL
    nonresponders

    Source sentences

    Summary
    attenuated changes in fasting glucose levels (26 weeks: 1 ± 16 mg/dL vs 5 ± 14 mg/dL [P = .01]; 52 weeks: -1 ± 14 mg/dL vs 8 ± 17 mg/dL [P < .001]
    2 context sentences
    Summary · context
    In 2 phase III, randomized, double-blind studies, men and women with HIV-associated abdominal fat accumulation were randomly assigned (ratio, 2:1) to receive tesamorelin or placebo for 26 weeks.
    Summary · context
    In per-protocol analysis of 402 subjects initially randomly assigned to receive tesamorelin, those with ≥8% reduction in VAT were defined a priori as responders per the statistical analysis plan.
  3. 03HumanObservational studyEfficacy outcome

    In HIV-infected patients treated with tesamorelin, VAT responders had attenuated rises in hemoglobin A1c compared with nonresponders.

    In plain wordsIn HIV-infected patients on tesamorelin, those whose belly fat fell 8% or more had smaller rises in HbA1c than those whose belly fat fell less.

    Outcome
    DecreaseHemoglobin A1c change in VAT responders vs nonresponders
    Study

    n = 402

    Comparator
    Tesamorelin nonresponders
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 26 to 52 weeksAs given in this study (human).

    Measurements

    HbA1c change at 26 weeks
    0.1%
    responders
    HbA1c change at 26 weeks
    0.3%
    nonresponders

    Source sentences

    Summary
    hemoglobin A1c levels (26 weeks: 0.1 ± 0.3% vs 0.3 ± 0.4% [P < .001]; 52 weeks: 0.0 ± 0.3% vs 0.2 ± 0.5% [P = .003]
    2 context sentences
    Summary · context
    In 2 phase III, randomized, double-blind studies, men and women with HIV-associated abdominal fat accumulation were randomly assigned (ratio, 2:1) to receive tesamorelin or placebo for 26 weeks.
    Summary · context
    In per-protocol analysis of 402 subjects initially randomly assigned to receive tesamorelin, those with ≥8% reduction in VAT were defined a priori as responders per the statistical analysis plan.
  4. 04HumanObservational studyEfficacy outcome

    In HIV-infected patients treated with tesamorelin, adiponectin improved significantly in VAT responders compared with nonresponders.

    In plain wordsIn HIV-infected patients on tesamorelin, adiponectin improved more in those whose belly fat fell 8% or more than in those whose belly fat fell less.

    Outcome
    IncreaseAdiponectin change in VAT responders vs nonresponders
    Study

    n = 402

    Comparator
    Tesamorelin nonresponders
    Outcome group
    Inflammation markers · Metabolic and weight
    Studied dose
    Dose not stated · 26 to 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Similar patterns were seen for adiponectin levels, with significant improvement in responders vs nonresponders.
    2 context sentences
    Summary · context
    In 2 phase III, randomized, double-blind studies, men and women with HIV-associated abdominal fat accumulation were randomly assigned (ratio, 2:1) to receive tesamorelin or placebo for 26 weeks.
    Summary · context
    In per-protocol analysis of 402 subjects initially randomly assigned to receive tesamorelin, those with ≥8% reduction in VAT were defined a priori as responders per the statistical analysis plan.
  5. 05HumanObservational studyMechanism

    In HIV-infected patients treated with tesamorelin, changes in lipid levels and glucose homeostasis were significantly associated with the percentage change in VAT.

    In plain wordsIn HIV-infected patients on tesamorelin, changes in blood fats and blood sugar control were linked to the percentage change in belly fat.

    Outcome
    Not applicableAssociation of lipid and glucose changes with VAT change
    Study

    n = 402

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    Dose not stated · 26 to 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Changes in lipid levels and glucose homeostasis were significantly associated with percentage change in VAT.
    2 context sentences
    Summary · context
    In 2 phase III, randomized, double-blind studies, men and women with HIV-associated abdominal fat accumulation were randomly assigned (ratio, 2:1) to receive tesamorelin or placebo for 26 weeks.
    Summary · context
    In per-protocol analysis of 402 subjects initially randomly assigned to receive tesamorelin, those with ≥8% reduction in VAT were defined a priori as responders per the statistical analysis plan.

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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