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Study · Randomized controlled trial · n = 412 · 2007

9 results

Metabolic effects of a growth hormone-releasing factor in patients with HIV.

Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S

The New England journal of medicine1 Dec 2007Cited by 139 (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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In HIV patients with abdominal fat, tesamorelin reduced visceral adipose tissue (VAT) versus placebo over 26 weeks.

    In plain wordsIn HIV patients with belly fat, tesamorelin reduced belly organ fat while placebo patients had an increase.

    Outcome
    DecreaseVAT percent change
    Study

    n = 412

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    VAT change
    −15.2%
    tesamorelin
    VAT change
    5%
    placebo

    Source sentences

    Summary
    The measure of visceral adipose tissue decreased by 15.2% in the tesamorelin group and increased by 5.0% in the placebo group
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In HIV patients with abdominal fat, tesamorelin lowered triglycerides versus placebo.

    In plain wordsIn HIV patients with belly fat, tesamorelin lowered triglycerides while placebo patients had an increase.

    Outcome
    DecreaseTriglycerides change
    Study

    n = 412

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    Triglycerides change
    −50 mg per deciliter
    tesamorelin
    Triglycerides change
    9 mg per deciliter
    placebo

    Source sentences

    Summary
    the levels of triglycerides decreased by 50 mg per deciliter and increased by 9 mg per deciliter, respectively
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In HIV patients with abdominal fat, tesamorelin lowered the ratio of total cholesterol to HDL cholesterol versus placebo.

    In plain wordsIn HIV patients with belly fat, tesamorelin lowered the cholesterol to HDL ratio while placebo patients had an increase.

    Outcome
    DecreaseTotal cholesterol to HDL cholesterol ratio change
    Study

    n = 412

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    Cholesterol/HDL ratio change
    −0.31
    tesamorelin
    Cholesterol/HDL ratio change
    0.21
    placebo

    Source sentences

    Summary
    the ratio of total cholesterol to HDL cholesterol decreased by 0.31 and increased by 0.21, respectively (P<0.001 for all comparisons).
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In HIV patients with abdominal fat, tesamorelin increased IGF-I versus placebo.

    In plain wordsIn HIV patients with belly fat, tesamorelin raised IGF-I levels while placebo patients had a small decrease.

    Outcome
    IncreaseIGF-I change
    Study

    n = 412

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    IGF-I change
    81%
    tesamorelin
    IGF-I change
    −5%
    placebo

    Source sentences

    Summary
    Levels of IGF-I increased by 81.0% in the tesamorelin group and decreased by 5.0% in the placebo group (P<0.001).
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In HIV patients with abdominal fat, total cholesterol improved significantly in the tesamorelin group.

    In plain wordsIn HIV patients with belly fat, total cholesterol improved significantly in the tesamorelin group.

    Outcome
    Direction not reportedTotal cholesterol
    Study

    n = 412

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Levels of total cholesterol and HDL cholesterol also improved significantly in the tesamorelin group.
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In HIV patients with abdominal fat, HDL cholesterol improved significantly in the tesamorelin group.

    In plain wordsIn HIV patients with belly fat, HDL cholesterol improved significantly in the tesamorelin group.

    Outcome
    Direction not reportedHDL cholesterol
    Study

    n = 412

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Levels of total cholesterol and HDL cholesterol also improved significantly in the tesamorelin group.
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.
  7. 07HumanRandomized controlled trialSafety outcome

    In HIV patients with abdominal fat, adverse events did not differ significantly between tesamorelin and placebo.

    In plain wordsIn HIV patients with belly fat, side effects did not differ significantly between tesamorelin and placebo.

    Outcome
    No significant changeAdverse events
    Study

    n = 412

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Adverse events did not differ significantly between the two study groups
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.
  8. 08HumanRandomized controlled trialSafety outcome

    In HIV patients with abdominal fat, more patients withdrew because of an adverse event with tesamorelin than with placebo.

    In plain wordsIn HIV patients with belly fat, more patients on tesamorelin than on placebo left the study because of a side effect.

    Outcome
    IncreaseWithdrawal due to adverse event
    Study

    n = 412

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    but more patients in the tesamorelin group withdrew from the study because of an adverse event.
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.
  9. 09HumanRandomized controlled trialSafety outcome

    In HIV patients with abdominal fat, glycemic measures (glucose and insulin) did not differ significantly between groups.

    In plain wordsIn HIV patients with belly fat, blood glucose and insulin did not differ significantly between tesamorelin and placebo.

    Outcome
    No significant changeGlycemic measures
    Study

    n = 412

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in glycemic measures.
    1 context sentence
    Summary · context
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.

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 · source ClinicalTrials.gov (opens in a new tab)

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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