Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension.

Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S

Journal of acquired immune deficiency syndromes (1999)1 Mar 2010Cited by 51 (Europe PMC)

PMID20101189DOI10.1097/qai.0b013e3181cbdaffPepBankPUB-20101189

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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 study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, tesamorelin reduced visceral adipose tissue more than placebo over 6 months.
In plain wordsIn HIV-infected adults with abdominal fat, tesamorelin reduced belly organ fat more than placebo.
Peptide
Tesamorelin
Outcome
DecreaseVisceral adipose tissue (VAT) change at 6 months
Study
n = 404
Comparator
Placebo
Analysis
Primary
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Measurements
VAT change
−10.9%
tesamorelin
VAT change
−0.6%
placebo
Source sentences
Summary
VAT decreased by -10.9% (-21 cm(2)) in the tesamorelin group vs. -0.6% (-1 cm(2)) in the placebo group in the 6-month efficacy phase, P < 0.0001.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118901
02HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, tesamorelin increased IGF-I.
In plain wordsIn HIV-infected adults with abdominal fat, tesamorelin raised IGF-I levels.
Peptide
Tesamorelin
Outcome
IncreaseIGF-I
Study
n = 404
Comparator
Placebo
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Insulin-like growth factor-1 increased (P < 0.001), but no change in glucose parameters was observed.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118907
03HumanRandomized controlled trialSafety outcome
In HIV-infected adults with abdominal fat, tesamorelin caused no change in glucose parameters.
In plain wordsIn HIV-infected adults with abdominal fat, tesamorelin did not change blood glucose measures.
Peptide
Tesamorelin
Outcome
No significant changeGlucose parameters
Study
n = 404
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Insulin-like growth factor-1 increased (P < 0.001), but no change in glucose parameters was observed.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118908
04HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, patient-rated belly appearance distress improved with tesamorelin versus placebo.
In plain wordsIn HIV-infected adults with abdominal fat, patients rated their belly appearance distress as better with tesamorelin than with placebo.
Peptide
Tesamorelin
Outcome
Direction not reportedPatient-rated belly appearance distress
Study
n = 404
Comparator
Placebo
Analysis
Secondary
Outcome group
Patient-reported outcomes · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Patient rating of belly appearance distress (P = 0.02) and physician rating of belly profile (P = 0.02) were significantly improved in the tesamorelin vs. placebo-treated groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118909
05HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, physician-rated belly profile improved with tesamorelin versus placebo.
In plain wordsIn HIV-infected adults with abdominal fat, physicians rated belly profile as better with tesamorelin than with placebo.
Peptide
Tesamorelin
Outcome
Direction not reportedPhysician-rated belly profile
Study
n = 404
Comparator
Placebo
Analysis
Secondary
Outcome group
Patient-reported outcomes · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Patient rating of belly appearance distress (P = 0.02) and physician rating of belly profile (P = 0.02) were significantly improved in the tesamorelin vs. placebo-treated groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118910
06HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, trunk fat improved with tesamorelin versus placebo over 6 months.
In plain wordsIn HIV-infected adults with abdominal fat, trunk fat improved with tesamorelin compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseTrunk fat
Study
n = 404
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Trunk fat (P < 0.001), waist circumference (P = 0.02), and waist-hip-ratio (P = 0.001) improved, with no change in limb or abdominal SC fat.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118902
07HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, waist circumference improved with tesamorelin versus placebo over 6 months.
In plain wordsIn HIV-infected adults with abdominal fat, waist size improved with tesamorelin compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseWaist circumference
Study
n = 404
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Trunk fat (P < 0.001), waist circumference (P = 0.02), and waist-hip-ratio (P = 0.001) improved, with no change in limb or abdominal SC fat.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118903
08HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, waist-hip ratio improved with tesamorelin versus placebo over 6 months.
In plain wordsIn HIV-infected adults with abdominal fat, waist-hip ratio improved with tesamorelin compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseWaist-hip ratio
Study
n = 404
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Trunk fat (P < 0.001), waist circumference (P = 0.02), and waist-hip-ratio (P = 0.001) improved, with no change in limb or abdominal SC fat.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118904
09HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, tesamorelin did not change limb fat.
In plain wordsIn HIV-infected adults with abdominal fat, tesamorelin did not change limb fat.
Peptide
Tesamorelin
Outcome
No significant changeLimb fat
Study
n = 404
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Trunk fat (P < 0.001), waist circumference (P = 0.02), and waist-hip-ratio (P = 0.001) improved, with no change in limb or abdominal SC fat.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118905
10HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat, tesamorelin did not change abdominal subcutaneous fat.
In plain wordsIn HIV-infected adults with abdominal fat, tesamorelin did not change the fat under the skin of the belly.
Peptide
Tesamorelin
Outcome
No significant changeAbdominal subcutaneous fat
Study
n = 404
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Trunk fat (P < 0.001), waist circumference (P = 0.02), and waist-hip-ratio (P = 0.001) improved, with no change in limb or abdominal SC fat.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118906
11HumanRandomized controlled trialSafety outcome
In HIV-infected adults with abdominal fat, the study reported tesamorelin was well tolerated.
In plain wordsIn HIV-infected adults with abdominal fat, tesamorelin was reported as well tolerated.
Peptide
Tesamorelin
Outcome
No significant changeTolerability
Study
n = 404
Outcome group
Adverse events · Whole body
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
The drug was well tolerated.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118911
12HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults who continued tesamorelin for 12 months, visceral adipose tissue was reduced by approximately 18%.
In plain wordsIn HIV-infected adults who stayed on tesamorelin for 12 months, belly organ fat fell by about 18%.
Peptide
Tesamorelin
Outcome
DecreaseVAT change at 12 months with continued tesamorelin
Study
n: not reported in source
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 12 monthsAs given in this study (human).
Measurements
VAT reduction
≈ 18%
continued tesamorelin 12 months
Source sentences
Summary
VAT was reduced by approximately 18% (P < 0.001) in patients continuing tesamorelin for 12 months.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118912
13HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults who switched from tesamorelin to placebo after 6 months, the earlier reduction in VAT was rapidly lost.
In plain wordsIn HIV-infected adults who switched from tesamorelin to placebo, the earlier drop in belly organ fat was quickly lost.
Peptide
Tesamorelin
Outcome
IncreaseVAT after switch from tesamorelin to placebo
Study
n: not reported in source
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg every day · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
The initial improvements over 6 months in VAT were rapidly lost in those switching from tesamorelin to placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008.
Report a problemFND-2010118913

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 page ClinicalTrials.govUpdated 30 Sept 2022

CompletedPhase 3NCT00123253

TH9507 in Patients With HIV-Associated Lipodystrophy

Theratechnologiesn = 412Jun 2005 to Apr 2007

HIV Infections · Lipodystrophy

Trial page ClinicalTrials.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.

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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Terms as the source lists them.

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