A placebo-controlled, dose-ranging study of a growth hormone releasing factor in HIV-infected patients with abdominal fat accumulation.

Falutz J, Allas S, Kotler D, Thompson M, Koutkia P, Albu J, Trottier B, Routy JP, Cote P, Abribat T, Grinspoon S

AIDS (London, England)1 Aug 2005Cited by 48 (Europe PMC)

PMID16052083DOI10.1097/01.aids.0000180099.35146.30PepBankPUB-16052083

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 study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, TH9507 1 mg daily increased IGF-I versus placebo.
In plain wordsIn HIV-infected adults with belly fat gain, TH9507 1 mg daily raised IGF-I compared with placebo.
Peptide
Tesamorelin
Outcome
IncreaseIGF-I increase (1 mg)
Study
n = 61
Comparator
Placebo
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
1 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
IGF-I change
48%
1 mg
Source sentences
Summary
TH9507 resulted in dose-related physiological increases in IGF-I (P < 0.01 for 1 mg (+48%) and 2 mg (+65%) versus placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208301
02HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, TH9507 2 mg daily increased IGF-I versus placebo.
In plain wordsIn HIV-infected adults with belly fat gain, TH9507 2 mg daily raised IGF-I compared with placebo.
Peptide
Tesamorelin
Outcome
IncreaseIGF-I increase (2 mg)
Study
n = 61
Comparator
Placebo
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
2 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
IGF-I change
65%
2 mg
Source sentences
Summary
TH9507 resulted in dose-related physiological increases in IGF-I (P < 0.01 for 1 mg (+48%) and 2 mg (+65%) versus placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208302
03HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, TH9507 2 mg reduced trunk fat versus placebo.
In plain wordsIn HIV-infected adults with belly fat gain, TH9507 2 mg reduced trunk fat compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseTrunk fat change
Study
n = 61
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Trunk fat change
−9.2%
2 mg
Trunk fat change
0.8%
placebo
Source sentences
Summary
Trunk fat decreased in the 2 mg group versus placebo (0.8, -4.6 and -9.2%; placebo, 1 and 2 mg, respectively, P = 0.014 for 2 mg versus placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208303
04HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, TH9507 caused no significant change in limb fat.
In plain wordsIn HIV-infected adults with belly fat gain, TH9507 did not significantly change limb fat.
Peptide
Tesamorelin
Outcome
No significant changeLimb fat change
Study
n = 61
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
1 and 2 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
without significant change in limb fat.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208304
05HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, visceral fat decreased most with TH9507 2 mg, but the change was not significant versus placebo.
In plain wordsIn HIV-infected adults with belly fat gain, belly organ fat fell most with TH9507 2 mg, but not significantly more than with placebo.
Peptide
Tesamorelin
Outcome
No significant changeVisceral fat (VAT) change
Study
n = 61
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg · subcutaneous · 12 weeksAs given in this study (human).
Measurements
VAT change
−15.7%
2 mg
VAT change
−3.6%
1 mg
VAT change
−5.4%
placebo
Source sentences
Summary
Visceral fat (VAT) decreased most in the 2 mg group (-5.4, -3.6 and -15.7%; placebo, 1 and 2 mg, respectively) but this change was not significant versus placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208305
06HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, subcutaneous fat was preserved and did not change between or within groups.
In plain wordsIn HIV-infected adults with belly fat gain, fat under the skin did not change with TH9507 or placebo.
Peptide
Tesamorelin
Outcome
No significant changeSubcutaneous fat (SAT) change
Study
n = 61
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
1 and 2 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Subcutaneous fat (SAT) was preserved and did not change between or within groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208306
07HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, lean body mass improved significantly in both TH9507 groups versus placebo.
In plain wordsIn HIV-infected adults with belly fat gain, lean body mass improved with both TH9507 doses compared with placebo.
Peptide
Tesamorelin
Outcome
IncreaseLean body mass
Study
n = 61
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
1 and 2 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Lean body mass and the ratio of VAT to SAT improved significantly in both treatment groups versus placebo
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208307
08HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, the VAT to SAT ratio improved significantly in both TH9507 groups versus placebo.
In plain wordsIn HIV-infected adults with belly fat gain, the ratio of belly organ fat to skin fat improved with both TH9507 doses compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseRatio of VAT to SAT
Study
n = 61
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
1 and 2 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Lean body mass and the ratio of VAT to SAT improved significantly in both treatment groups versus placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208308
09HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, TH9507 2 mg reduced triglycerides significantly versus placebo.
In plain wordsIn HIV-infected adults with belly fat gain, TH9507 2 mg lowered triglycerides compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseTriglyceride change
Study
n = 61
Comparator
Placebo
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Triglyceride and the cholesterol to high-density lipoprotein ratio decreased significantly in the 2 mg group versus placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208309
10HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with central fat accumulation, TH9507 2 mg reduced the cholesterol to HDL ratio significantly versus placebo.
In plain wordsIn HIV-infected adults with belly fat gain, TH9507 2 mg lowered the cholesterol to HDL ratio compared with placebo.
Peptide
Tesamorelin
Outcome
DecreaseCholesterol to HDL ratio change
Study
n = 61
Comparator
Placebo
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Triglyceride and the cholesterol to high-density lipoprotein ratio decreased significantly in the 2 mg group versus placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208310
11HumanRandomized controlled trialSafety outcome
In HIV-infected adults with central fat accumulation, TH9507 was reported as generally well tolerated.
In plain wordsIn HIV-infected adults with belly fat gain, TH9507 was reported as generally well tolerated.
Peptide
Tesamorelin
Outcome
No significant changeTolerability
Study
n = 61
Outcome group
Adverse events · Whole body
Studied dose
1 and 2 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Treatment was generally well tolerated
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208311
12HumanRandomized controlled trialSafety outcome
In HIV-infected adults with central fat accumulation, TH9507 did not change glucose.
In plain wordsIn HIV-infected adults with belly fat gain, TH9507 did not change blood glucose.
Peptide
Tesamorelin
Outcome
No significant changeGlucose
Study
n = 61
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 and 2 mg · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Treatment was generally well tolerated without changes in glucose.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled trial enrolling 61 HIV-infected patients with increased waist circumference and waist-to-hip ratio.
Summary · context
Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.
Report a problemFND-1605208312

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

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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