Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data.

Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S

The Journal of clinical endocrinology and metabolism16 Jun 2010Cited by 78 (Europe PMC)

PMID20554713DOI10.1210/jc.2010-0490PepBankPUB-20554713

Publisher page PubMedAsk about this study

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 study15

15 results from studies that gave the peptide. 15 results from people.

01HumanRandomized controlled trialEfficacy outcome
In HIV patients with excess abdominal fat, tesamorelin reduced visceral adipose tissue (VAT) versus placebo at week 26.
In plain wordsIn HIV patients with excess belly fat, tesamorelin reduced belly organ fat compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseVAT change at week 26
Study
n = 806
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
−24 cm(2)
tesamorelin
VAT change
2 cm(2)
placebo
Treatment effect on VAT
−15.4%
tesamorelin vs placebo
Source sentences
Summary
At wk 26, VAT decreased significantly in tesamorelin-treated patients (-24 +/- 41 vs. 2 +/- 35 cm(2), tesamorelin vs. placebo, P < 0.001; treatment effect, -15.4%).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471301
02HumanRandomized controlled trialEfficacy outcome
In HIV patients with excess abdominal fat, tesamorelin did not significantly change abdominal subcutaneous adipose tissue versus placebo.
In plain wordsIn HIV patients with excess belly fat, tesamorelin did not significantly change fat under the belly skin compared with placebo.
Peptide
Tesamorelin
Outcome
No significant changeAbdominal subcutaneous adipose tissue change
Study
n = 806
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Abdominal SC adipose tissue change
−2 cm(2)
tesamorelin
Abdominal SC adipose tissue change
2 cm(2)
placebo
Source sentences
Summary
No significant changes were observed in abdominal sc adipose tissue (-2 +/- 32 vs. 2 +/- 29 cm(2), P = 0.08; treatment effect, -0.6%).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471302
03HumanRandomized controlled trialEfficacy outcome
In HIV patients with excess abdominal fat, tesamorelin reduced triglycerides versus placebo at week 26.
In plain wordsIn HIV patients with excess belly fat, tesamorelin lowered triglycerides compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseTriglycerides change
Study
n = 806
Comparator
Placebo
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Triglycerides change
−37 mg/dl
tesamorelin
Triglycerides change
6 mg/dl
placebo
Treatment effect on triglycerides
−12.3%
tesamorelin vs placebo
Source sentences
Summary
Treatment with tesamorelin resulted in significant decreases in triglycerides (-37 +/- 139 vs. 6 +/- 112 mg/dl, P < 0.001; treatment effect, -12.3%) and cholesterol to high-density lipoprotein ratio (-0.18 +/- 1.00 vs. 0.18 +/- 0.94, P < 0.001; treatment effect, -7.2%) vs. placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471303
04HumanRandomized controlled trialEfficacy outcome
In HIV patients with excess abdominal fat, tesamorelin reduced the cholesterol to HDL ratio versus placebo at week 26.
In plain wordsIn HIV patients with excess belly fat, tesamorelin lowered the cholesterol to HDL ratio compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseCholesterol to HDL ratio change
Study
n = 806
Comparator
Placebo
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Cholesterol/HDL ratio change
−0.18
tesamorelin
Cholesterol/HDL ratio change
0.18
placebo
Treatment effect on cholesterol/HDL ratio
−7.2%
tesamorelin vs placebo
Source sentences
Summary
Treatment with tesamorelin resulted in significant decreases in triglycerides (-37 +/- 139 vs. 6 +/- 112 mg/dl, P < 0.001; treatment effect, -12.3%) and cholesterol to high-density lipoprotein ratio (-0.18 +/- 1.00 vs. 0.18 +/- 0.94, P < 0.001; treatment effect, -7.2%) vs. placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471304
05HumanRandomized controlled trialEfficacy outcome
In HIV patients with excess abdominal fat, tesamorelin improved belly appearance distress.
In plain wordsIn HIV patients with excess belly fat, tesamorelin improved how distressed patients felt about their belly appearance.
Peptide
Tesamorelin
Outcome
Direction not reportedBelly appearance distress
Study
n = 806
Comparator
Placebo
Outcome group
Patient-reported outcomes · Metabolic and weight
Studied dose
2 mg · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
Tesamorelin improved body image [belly appearance distress (P = 0.002)], patient rating of belly profile (P = 0.003), and physician rating of belly profile (P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471305
06HumanRandomized controlled trialEfficacy outcome
In HIV patients with excess abdominal fat, tesamorelin improved the patient rating of belly profile.
In plain wordsIn HIV patients with excess belly fat, tesamorelin improved how patients rated their belly profile.
Peptide
Tesamorelin
Outcome
Direction not reportedPatient rating of belly profile
Study
n = 806
Comparator
Placebo
Outcome group
Patient-reported outcomes · Metabolic and weight
Studied dose
2 mg · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
Tesamorelin improved body image [belly appearance distress (P = 0.002)], patient rating of belly profile (P = 0.003), and physician rating of belly profile (P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471306
07HumanRandomized controlled trialEfficacy outcome
In HIV patients with excess abdominal fat, tesamorelin improved the physician rating of belly profile.
In plain wordsIn HIV patients with excess belly fat, tesamorelin improved how physicians rated belly profile.
Peptide
Tesamorelin
Outcome
Direction not reportedPhysician rating of belly profile
Study
n = 806
Comparator
Placebo
Outcome group
Patient-reported outcomes · Metabolic and weight
Studied dose
2 mg · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
Tesamorelin improved body image [belly appearance distress (P = 0.002)], patient rating of belly profile (P = 0.003), and physician rating of belly profile (P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471307
08HumanRandomized controlled trialEfficacy outcome
In HIV patients with excess abdominal fat, tesamorelin increased mean IGF-I versus placebo.
In plain wordsIn HIV patients with excess belly fat, tesamorelin raised IGF-I levels compared with placebo.
Peptide
Tesamorelin
Outcome
IncreaseIGF-I change
Study
n = 806
Comparator
Placebo
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
108 ng/ml
tesamorelin
IGF-I change
−7 ng/ml
placebo
Source sentences
Summary
Mean IGF-I increased 108 +/- 112 vs.-7 +/- 64 ng/ml (P < 0.001 vs. placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471308
09HumanRandomized controlled trialSafety outcome
In HIV patients with excess abdominal fat, tesamorelin was reported as generally well tolerated.
In plain wordsIn HIV patients with excess belly fat, tesamorelin was reported as generally well tolerated.
Peptide
Tesamorelin
Outcome
No significant changeTolerability
Study
n = 806
Outcome group
Adverse events · Whole body
Studied dose
2 mg · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
Treatment with tesamorelin was generally well tolerated.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471314
10HumanRandomized controlled trialSafety outcome
In HIV patients with excess abdominal fat, glucose parameters did not differ in a clinically meaningful way between groups at weeks 26 and 52.
In plain wordsIn HIV patients with excess belly fat, blood glucose measures did not differ in a meaningful way between tesamorelin and placebo groups.
Peptide
Tesamorelin
Outcome
No significant changeGlucose parameters at weeks 26 and 52
Study
n = 806
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 clinically meaningful differences were observed between groups in glucose parameters at wk 26 and 52.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471315
11HumanRandomized controlled trialEfficacy outcome
In HIV patients who continued tesamorelin to week 52, the reduction in VAT was maintained versus original baseline.
In plain wordsIn HIV patients who stayed on tesamorelin for 52 weeks, the loss of belly organ fat was kept off compared with the start.
Peptide
Tesamorelin
Outcome
DecreaseVAT change at week 52 (T-T group)
Study
n = 246
Comparator
Original baseline
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg · subcutaneous · 52 weeksAs given in this study (human).
Measurements
VAT change
−35 cm(2)
T-T group week 52
VAT change
−17.5%
T-T group week 52
Source sentences
Summary
At wk 52, decreases in VAT [-35 +/- 50 cm(2) (-17.5 +/- 23.3%)], waist circumference (-3.4 +/- 6.0 cm), triglycerides (-48 +/- 182 mg/dl), cholesterol (-8 +/- 38 mg/dl), and non-high-density lipoprotein (-7 +/- 38 mg/dl) were maintained (all P < 0.001 vs. original baseline) in the T-T group.
2 context sentences(design, population, supporting numbers)
Summary · context
At wk 26, patients initially on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 246) or placebo (T-P, n = 135) for an additional 26 wk, whereas patients on placebo were switched to tesamorelin (P-T, n = 197).
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471309
12HumanRandomized controlled trialEfficacy outcome
In HIV patients who continued tesamorelin to week 52, the reduction in waist circumference was maintained versus original baseline.
In plain wordsIn HIV patients who stayed on tesamorelin for 52 weeks, the smaller waist size was kept compared with the start.
Peptide
Tesamorelin
Outcome
DecreaseWaist circumference change at week 52 (T-T group)
Study
n = 246
Comparator
Original baseline
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Waist circumference change
−3.4 cm
T-T group week 52
Source sentences
Summary
At wk 52, decreases in VAT [-35 +/- 50 cm(2) (-17.5 +/- 23.3%)], waist circumference (-3.4 +/- 6.0 cm), triglycerides (-48 +/- 182 mg/dl), cholesterol (-8 +/- 38 mg/dl), and non-high-density lipoprotein (-7 +/- 38 mg/dl) were maintained (all P < 0.001 vs. original baseline) in the T-T group.
2 context sentences(design, population, supporting numbers)
Summary · context
At wk 26, patients initially on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 246) or placebo (T-P, n = 135) for an additional 26 wk, whereas patients on placebo were switched to tesamorelin (P-T, n = 197).
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471310
13HumanRandomized controlled trialEfficacy outcome
In HIV patients who continued tesamorelin to week 52, the reduction in triglycerides was maintained versus original baseline.
In plain wordsIn HIV patients who stayed on tesamorelin for 52 weeks, the lower triglycerides were kept compared with the start.
Peptide
Tesamorelin
Outcome
DecreaseTriglycerides change at week 52 (T-T group)
Study
n = 246
Comparator
Original baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Triglycerides change
−48 mg/dl
T-T group week 52
Source sentences
Summary
At wk 52, decreases in VAT [-35 +/- 50 cm(2) (-17.5 +/- 23.3%)], waist circumference (-3.4 +/- 6.0 cm), triglycerides (-48 +/- 182 mg/dl), cholesterol (-8 +/- 38 mg/dl), and non-high-density lipoprotein (-7 +/- 38 mg/dl) were maintained (all P < 0.001 vs. original baseline) in the T-T group.
2 context sentences(design, population, supporting numbers)
Summary · context
At wk 26, patients initially on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 246) or placebo (T-P, n = 135) for an additional 26 wk, whereas patients on placebo were switched to tesamorelin (P-T, n = 197).
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471311
14HumanRandomized controlled trialEfficacy outcome
In HIV patients who continued tesamorelin to week 52, the reduction in cholesterol was maintained versus original baseline.
In plain wordsIn HIV patients who stayed on tesamorelin for 52 weeks, the lower cholesterol was kept compared with the start.
Peptide
Tesamorelin
Outcome
DecreaseCholesterol change at week 52 (T-T group)
Study
n = 246
Comparator
Original baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Cholesterol change
−8 mg/dl
T-T group week 52
Source sentences
Summary
At wk 52, decreases in VAT [-35 +/- 50 cm(2) (-17.5 +/- 23.3%)], waist circumference (-3.4 +/- 6.0 cm), triglycerides (-48 +/- 182 mg/dl), cholesterol (-8 +/- 38 mg/dl), and non-high-density lipoprotein (-7 +/- 38 mg/dl) were maintained (all P < 0.001 vs. original baseline) in the T-T group.
2 context sentences(design, population, supporting numbers)
Summary · context
At wk 26, patients initially on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 246) or placebo (T-P, n = 135) for an additional 26 wk, whereas patients on placebo were switched to tesamorelin (P-T, n = 197).
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471312
15HumanRandomized controlled trialEfficacy outcome
In HIV patients who continued tesamorelin to week 52, the reduction in non-HDL cholesterol was maintained versus original baseline.
In plain wordsIn HIV patients who stayed on tesamorelin for 52 weeks, the lower non-HDL cholesterol was kept compared with the start.
Peptide
Tesamorelin
Outcome
DecreaseNon-HDL cholesterol change at week 52 (T-T group)
Study
n = 246
Comparator
Original baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Non-HDL cholesterol change
−7 mg/dl
T-T group week 52
Source sentences
Summary
At wk 52, decreases in VAT [-35 +/- 50 cm(2) (-17.5 +/- 23.3%)], waist circumference (-3.4 +/- 6.0 cm), triglycerides (-48 +/- 182 mg/dl), cholesterol (-8 +/- 38 mg/dl), and non-high-density lipoprotein (-7 +/- 38 mg/dl) were maintained (all P < 0.001 vs. original baseline) in the T-T group.
2 context sentences(design, population, supporting numbers)
Summary · context
At wk 26, patients initially on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 246) or placebo (T-P, n = 135) for an additional 26 wk, whereas patients on placebo were switched to tesamorelin (P-T, n = 197).
Summary · context
A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily.
Report a problemFND-2055471313

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

Subjects

Terms as the source lists them.

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MeSH terms

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