Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial.

Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK

JAMA1 Jul 2014Cited by 69 (Europe PMC)

PMID25038357PMCIDPMC4363137DOI10.1001/jama.2014.8334PepBankPUB-25038357

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.

01HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat accumulation, tesamorelin reduced visceral adipose tissue more than placebo over 6 months.
In plain wordsIn HIV-infected adults with abdominal fat, tesamorelin reduced belly (visceral) fat more than placebo over 6 months.
Peptide
Tesamorelin
Outcome
DecreaseVisceral adipose tissue change over 6 months
Study
n = 48
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg · subcutaneous · 6 monthsAs given in this study (human).
Measurements
VAT change
−34 cm2
tesamorelin
VAT change
8 cm2
placebo
Treatment effect
−42 cm2
tesamorelin vs placebo
Source sentences
Summary
Tesamorelin significantly reduced visceral adipose tissue (mean change, -34 cm2 [95% CI, -53 to -15 cm2] with tesamorelin vs 8 cm2 [95% CI, -14 to 30 cm2] with placebo; treatment effect, -42 cm2 [95% CI, -71 to -14 cm2]; P = .005)
3 context sentences(design, population, supporting numbers)
Summary · context
Primary end points were changes in visceral adipose tissue and liver fat.
Summary · context
Double-blind, randomized, placebo-controlled trial conducted among 50 antiretroviral-treated HIV-infected men and women with abdominal fat accumulation at Massachusetts General Hospital in Boston.
Summary · context
Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.
Report a problemFND-2503835701
02HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat accumulation, tesamorelin reduced liver fat more than placebo over 6 months.
In plain wordsIn HIV-infected adults with abdominal fat, tesamorelin reduced liver fat more than placebo over 6 months.
Peptide
Tesamorelin
Outcome
DecreaseLiver fat change over 6 months
Study
n = 48
Comparator
Placebo
Analysis
Primary
Outcome group
Liver fat and liver function · Liver
Studied dose
2 mg · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Median liver fat change (lipid to water)
−2%
tesamorelin
Median liver fat change (lipid to water)
0.9%
placebo
Net treatment effect
−2.9%
tesamorelin vs placebo
Source sentences
Summary
liver fat (median change in lipid to water percentage, -2.0% [interquartile range {IQR}, -6.4% to 0.1%] with tesamorelin vs 0.9% [IQR, -0.6% to 3.7%] with placebo; P = .003) over 6 months, for a net treatment effect of -2.9% in lipid to water percentage.
3 context sentences(design, population, supporting numbers)
Summary · context
Primary end points were changes in visceral adipose tissue and liver fat.
Summary · context
Double-blind, randomized, placebo-controlled trial conducted among 50 antiretroviral-treated HIV-infected men and women with abdominal fat accumulation at Massachusetts General Hospital in Boston.
Summary · context
Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.
Report a problemFND-2503835702
03HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat accumulation, fasting glucose rose more with tesamorelin than with placebo at 2 weeks.
In plain wordsIn HIV-infected adults with abdominal fat, fasting blood sugar rose more with tesamorelin than with placebo at 2 weeks.
Peptide
Tesamorelin
Outcome
IncreaseFasting glucose change at 2 weeks
Study
n = 48
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Fasting glucose change at 2 weeks
9 mg/dL
tesamorelin
Fasting glucose change at 2 weeks
2 mg/dL
placebo
Treatment effect
7 mg/dL
tesamorelin vs placebo
Source sentences
Summary
Fasting glucose increased in the tesamorelin group at 2 weeks (mean change, 9 mg/dL [95% CI, 5-13 mg/dL] vs 2 mg/dL [95% CI, -3 to 8 mg/dL] in the placebo group; treatment effect, 7 mg/dL [95% CI, 1-14 mg/dL]; P = .03)
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary end points included glucose levels and other metabolic end points.
Summary · context
Double-blind, randomized, placebo-controlled trial conducted among 50 antiretroviral-treated HIV-infected men and women with abdominal fat accumulation at Massachusetts General Hospital in Boston.
Summary · context
Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.
Report a problemFND-2503835703
04HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat accumulation, the change in fasting glucose at 6 months did not differ significantly between tesamorelin and placebo.
In plain wordsIn HIV-infected adults with abdominal fat, fasting blood sugar at 6 months did not differ significantly between tesamorelin and placebo.
Peptide
Tesamorelin
Outcome
No significant changeFasting glucose change at 6 months
Study
n = 48
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Treatment effect on fasting glucose at 6 months
2 mg/dL
tesamorelin vs placebo
Source sentences
Summary
but changes at 6 months in fasting glucose (mean change, 4 mg/dL [95% CI, -2 to 10 mg/dL] with tesamorelin vs 2 mg/dL [95% CI, -4 to 7 mg/dL] with placebo; treatment effect, 2 mg/dL [95% CI, -6 to 10 mg/dL]; P = .72 overall across time points)
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary end points included glucose levels and other metabolic end points.
Summary · context
Double-blind, randomized, placebo-controlled trial conducted among 50 antiretroviral-treated HIV-infected men and women with abdominal fat accumulation at Massachusetts General Hospital in Boston.
Summary · context
Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.
Report a problemFND-2503835704
05HumanRandomized controlled trialEfficacy outcome
In HIV-infected adults with abdominal fat accumulation, 2-hour glucose did not change significantly differently with tesamorelin than with placebo.
In plain wordsIn HIV-infected adults with abdominal fat, 2-hour blood sugar did not differ significantly between tesamorelin and placebo.
Peptide
Tesamorelin
Outcome
No significant change2-hour glucose change
Study
n = 48
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Treatment effect on 2-hour glucose
7 mg/dL
tesamorelin vs placebo
Source sentences
Summary
and 2-hour glucose (mean change, -1 mg/dL [95% CI, -18 to 15 mg/dL] vs -8 mg/dL [95% CI, -24 to 8 mg/dL], respectively; treatment effect, 7 mg/dL [95% CI, -16 to 29 mg/dL]; P = .53 overall across time points) were not significant.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary end points included glucose levels and other metabolic end points.
Summary · context
Double-blind, randomized, placebo-controlled trial conducted among 50 antiretroviral-treated HIV-infected men and women with abdominal fat accumulation at Massachusetts General Hospital in Boston.
Summary · context
Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.
Report a problemFND-2503835705

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableResults postedNCT01263717

Effects of Growth Hormone Releasing Hormone in HIV

Massachusetts General Hospitaln = 54Dec 2010 to Feb 2014

HIV · HIV Lipodystrophy

Trial page ClinicalTrials.govUpdated 30 Oct 2017

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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