Predictors of Treatment Response to Tesamorelin, a Growth Hormone-Releasing Factor Analog, in HIV-Infected Patients with Excess Abdominal Fat.

Mangili A, Falutz J, Mamputu JC, Stepanians M, Hayward B

PloS one12 Oct 2015Cited by 7 (Europe PMC)

PMID26457580PMCIDPMC4601733DOI10.1371/journal.pone.0140358PepBankPUB-26457580

Summary

BackgroundTesamorelin, a synthetic analog of human growth hormone-releasing factor, decreases visceral adipose tissue (VAT) in human immunodeficiency virus (HIV)-infected patients with lipodystrophy.Objectives1) To evaluate the utility of patient characteristics and validated disease-risk scores, namely indicator variables for the metabolic syndrome defined by the International Diabetes Federation (MetS-IDF) or the National Cholesterol Education Program (MetS-NCEP) and the Framingham Risk Score (FRS), as predictors of VAT reduction during tesamorelin therapy at 3 and 6 months, and 2) To explore the characteristics of patients who reached a threshold of VAT <140 cm2, a level associated with lower risk of adverse health outcomes, after 6 months of treatment with tesamorelin.MethodsData were analyzed from two Phase 3 studies in which HIV-infected patients with excess abdominal fat were randomized in a 2:1 ratio to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) subcutaneously daily for 6 months, using ANOVA and ANCOVA models.ResultsMetabolic syndrome (MetS-IDF or MetS-NCEP) and FRS were significantly associated with VAT at baseline. Presence of metabolic syndrome ([MetS-NCEP), triglyceride levels >1.7 mmol/L, and white race had a significant impact on likelihood of response to tesamorelin after 6 months of therapy (interaction p-values 0.054, 0.063, and 0.025, respectively). No predictive factors were identified at 3 months. The odds of a VAT reduction to <140 cm2 for subjects treated with tesamorelin was 3.9 times greater than that of subjects randomized to placebo after controlling for study, gender, baseline body mass index (BMI) and baseline VAT (95% confidence interval [CI] 2.03; 7.44).ConclusionsIndividuals with baseline MetS-NCEP, elevated triglyceride levels, or white race were most likely to experience reductions in VAT after 6 months of tesamorelin treatment. The odds of response of VAT <140 cm2 was 3.9 times greater for tesamorelin-treated patients than that of patients receiving placebo.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In HIV-infected patients with excess abdominal fat, the interaction of metabolic syndrome (MetS-NCEP) with the likelihood of response to tesamorelin after 6 months was borderline (interaction p = 0.054), although the abstract called it significant.
In plain wordsIn people with HIV and extra belly fat, metabolic syndrome showed only a borderline link to belly fat response to tesamorelin.
Peptide
Tesamorelin
Outcome
Not applicableMetabolic syndrome (MetS-NCEP) as predictor of visceral fat response
Study
n = 806
Comparator
Placebo
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg daily · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Interaction p-value
0.054
MetS-NCEP
Source sentences
Summary
Presence of metabolic syndrome ([MetS-NCEP), triglyceride levels >1.7 mmol/L, and white race had a significant impact on likelihood of response to tesamorelin after 6 months of therapy (interaction p-values 0.054, 0.063, and 0.025, respectively)
1 context sentence(design, population, supporting numbers)
Summary · context
Data were analyzed from two Phase 3 studies in which HIV-infected patients with excess abdominal fat were randomized in a 2:1 ratio to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) subcutaneously daily for 6 months, using ANOVA and ANCOVA models.
Show in the study text Report a problemFND-2645758001
02HumanRandomized controlled trialEfficacy outcome
In HIV-infected patients with excess abdominal fat, the interaction of triglyceride levels above 1.7 mmol/L with the likelihood of response to tesamorelin after 6 months was borderline (interaction p = 0.063), although the abstract called it significant.
In plain wordsIn people with HIV and extra belly fat, high triglycerides showed only a borderline link to how likely belly fat was to fall with tesamorelin.
Peptide
Tesamorelin
Outcome
Not applicableTriglyceride level above 1.7 mmol/L as predictor of visceral fat response
Study
n = 806
Comparator
Placebo
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg daily · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Interaction p-value
0.063
triglycerides above 1.7 mmol/L
Source sentences
Summary
Presence of metabolic syndrome ([MetS-NCEP), triglyceride levels >1.7 mmol/L, and white race had a significant impact on likelihood of response to tesamorelin after 6 months of therapy (interaction p-values 0.054, 0.063, and 0.025, respectively)
1 context sentence(design, population, supporting numbers)
Summary · context
Data were analyzed from two Phase 3 studies in which HIV-infected patients with excess abdominal fat were randomized in a 2:1 ratio to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) subcutaneously daily for 6 months, using ANOVA and ANCOVA models.
Show in the study text Report a problemFND-2645758002
03HumanRandomized controlled trialEfficacy outcome
In HIV-infected patients with excess abdominal fat, white race influenced the likelihood of response to tesamorelin after 6 months.
In plain wordsIn people with HIV and extra belly fat, white race was linked to how likely belly fat was to fall with tesamorelin.
Peptide
Tesamorelin
Outcome
Not applicableWhite race as predictor of visceral fat response
Study
n = 806
Comparator
Placebo
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg daily · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Interaction p-value
0.025
white race
Source sentences
Summary
Presence of metabolic syndrome ([MetS-NCEP), triglyceride levels >1.7 mmol/L, and white race had a significant impact on likelihood of response to tesamorelin after 6 months of therapy (interaction p-values 0.054, 0.063, and 0.025, respectively)
1 context sentence(design, population, supporting numbers)
Summary · context
Data were analyzed from two Phase 3 studies in which HIV-infected patients with excess abdominal fat were randomized in a 2:1 ratio to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) subcutaneously daily for 6 months, using ANOVA and ANCOVA models.
Show in the study text Report a problemFND-2645758003
04HumanRandomized controlled trialEfficacy outcome
In HIV-infected patients with excess abdominal fat, no predictive factors of response to tesamorelin were identified at 3 months.
In plain wordsIn people with HIV and extra belly fat, no factor predicted how well tesamorelin worked at 3 months.
Peptide
Tesamorelin
Outcome
No significant changePredictors of visceral fat response at 3 months
Study
n = 806
Comparator
Placebo
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg daily · subcutaneous · 3 monthsAs given in this study (human).
Source sentences
Summary
No predictive factors were identified at 3 months.
1 context sentence(design, population, supporting numbers)
Summary · context
Data were analyzed from two Phase 3 studies in which HIV-infected patients with excess abdominal fat were randomized in a 2:1 ratio to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) subcutaneously daily for 6 months, using ANOVA and ANCOVA models.
Show in the study text Report a problemFND-2645758004
05HumanRandomized controlled trialEfficacy outcome
In HIV-infected patients with excess abdominal fat, the odds of reducing visceral fat below 140 cm2 were 3.9 times greater with tesamorelin than with placebo.
In plain wordsIn people with HIV and extra belly fat, the odds of belly fat below 140 cm2 were 3.9 times higher with tesamorelin than placebo.
Peptide
Tesamorelin
Outcome
IncreaseVisceral fat reduction to below 140 cm2 at 6 months
Study
n = 806
Comparator
Placebo
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg daily · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Odds ratio, VAT below 140 cm2
3.9 times
tesamorelin vs placebo, 6 months
Source sentences
Summary
The odds of a VAT reduction to <140 cm2 for subjects treated with tesamorelin was 3.9 times greater than that of subjects randomized to placebo after controlling for study, gender, baseline body mass index (BMI) and baseline VAT (95% confidence interval [CI] 2.03; 7.44).
1 context sentence(design, population, supporting numbers)
Summary · context
Data were analyzed from two Phase 3 studies in which HIV-infected patients with excess abdominal fat were randomized in a 2:1 ratio to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) subcutaneously daily for 6 months, using ANOVA and ANCOVA models.
Show in the study text Report a problemFND-2645758005

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.

Publication types

MeSH terms

PepBank is a research reference. Talk to a doctor before you use any peptide.