Skip to content

Study · Randomized controlled trial · 2021

6 results

Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women.

Rodgers M, Migdal AL, Rodríguez TG, Chen ZZ, Nath AK, Gerszten RE, Kasid N, Toschi E, Tripaldi J, Heineman B, Phan M, Ngo L, Maratos-Flier E, Dushay J

Frontiers in endocrinology17 Nov 2021Cited by 24 (Europe PMC)

PMID34867786 (opens in a new tab)PMCIDPMC8635796 (opens in a new tab)DOI10.3389/fendo.2021.742873 (opens in a new tab)PepBankPUB-34867786
Download PDFPubMedAsk about this study
Jump to 6 results

Summary

ObjectiveAs there is significant heterogeneity in the weight loss response to pharmacotherapy, one of the most important clinical questions in obesity medicine is how to predict an individual's response to pharmacotherapy. The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.MethodsWe randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet. In both treatment groups, women who demonstrated ≥ 5% weight loss at 12 weeks were characterized as high responders and those who lost ≥10% of body weight were classified as super responders. Our primary outcome was long-term change in body weight among early high responders to either treatment. An exploratory metabolomic analysis was also performed.ResultsWe observed individual variability in weight loss with both exenatide and hypocaloric diet plus placebo injections. There was a trend toward a higher percentage of subjects who achieved ≥ 5% weight loss with exenatide compared to diet (56% of those treated with exenatide, 76% of those treated with diet, p = 0.05) but no significant difference in those who achieved ≥ 10% weight loss (23% of individuals treated with exenatide and 36% of those treated with diet, p = 0.55). In both treatment groups, higher weight loss at 3 months of treatment predicted super responder status (diet p=0.0098, exenatide p=0.0080). Both treatment groups also demonstrated similar peak weight loss during the study period. We observed lower cysteine concentrations in the exenatide responder group (0.81 vs 0.48 p < 0.0001) and a trend toward higher levels of serotonin, aminoisobutyric acid, anandamide, and sarcosine in the exenatide super responder group.ConclusionIn a population of early high responders, longer term weight loss with exenatide treatment is similar to that achieved with a hypocaloric diet.Clinical trial registrationwww.clinicaltrialsgov, identifier NCT01590433.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In overweight or obese women, 56% on exenatide and 76% on hypocaloric diet plus placebo reached at least 5% weight loss (p = 0.05); the abstract calls this a trend toward more with exenatide.

    In plain wordsIn overweight or obese women, 56% on exenatide and 76% on diet plus placebo lost at least 5% of weight (p = 0.05).

    Peptide
    Exenatide (exendin-4)
    Outcome
    MixedAt least five-percent weight loss
    Study

    n: not reported in source

    Comparator
    Hypocaloric diet plus placebo injections
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    At least 5% weight loss
    56%
    exenatide
    At least 5% weight loss
    76%
    diet

    Source sentences

    Summary
    There was a trend toward a higher percentage of subjects who achieved ≥ 5% weight loss with exenatide compared to diet (56% of those treated with exenatide, 76% of those treated with diet, p = 0.05)
    2 context sentences
    Summary · context
    The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.
    Summary · context
    We randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In overweight or obese women, the proportion losing at least 10% did not differ significantly between exenatide and diet plus placebo.

    In plain wordsIn overweight or obese women, the proportion losing at least 10% did not differ significantly between exenatide and diet plus placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeAt least ten-percent weight loss
    Study

    n: not reported in source

    Comparator
    Hypocaloric diet plus placebo injections
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    At least 10% weight loss
    23%
    exenatide
    At least 10% weight loss
    36%
    diet

    Source sentences

    Summary
    but no significant difference in those who achieved ≥ 10% weight loss (23% of individuals treated with exenatide and 36% of those treated with diet, p = 0.55).
    2 context sentences
    Summary · context
    The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.
    Summary · context
    We randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In overweight or obese women, peak weight loss was similar with exenatide and hypocaloric diet plus placebo.

    In plain wordsIn overweight or obese women, peak weight loss was similar with exenatide and diet plus placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changePeak weight loss
    Study

    n: not reported in source

    Comparator
    Hypocaloric diet plus placebo injections
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Both treatment groups also demonstrated similar peak weight loss during the study period.
    2 context sentences
    Summary · context
    The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.
    Summary · context
    We randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet.
  4. 04HumanObservational studyMechanism

    In women given exenatide, cysteine concentrations were lower in the exenatide responder group (0.81 vs 0.48, p < 0.0001); the abstract does not state the comparison group.

    In plain wordsIn women given exenatide, cysteine levels were lower in responders; the abstract does not say what they were compared with.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseCysteine concentration
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Metabolic pathways and metabolomics · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Cysteine concentration
    0.81 not stated in source
    first value of '0.81 vs 0.48'; group labels not stated
    Cysteine concentration
    0.48 not stated in source
    second value of '0.81 vs 0.48'; group labels not stated

    Source sentences

    Summary
    We observed lower cysteine concentrations in the exenatide responder group (0.81 vs 0.48 p < 0.0001)
    3 context sentences
    Summary · context
    An exploratory metabolomic analysis was also performed.
    Summary · context
    The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.
    Summary · context
    We randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet.
  5. 05HumanObservational studyMechanism

    In women given exenatide, the abstract reports a trend toward higher serotonin, aminoisobutyric acid, anandamide and sarcosine levels in the exenatide super responder group, without naming a comparator.

    In plain wordsIn women given exenatide, four blood chemicals tended to be higher in super responders; the comparison group is not stated.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseSerotonin, aminoisobutyric acid, anandamide and sarcosine levels
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Metabolic pathways and metabolomics · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    and a trend toward higher levels of serotonin, aminoisobutyric acid, anandamide, and sarcosine in the exenatide super responder group.
    3 context sentences
    Summary · context
    An exploratory metabolomic analysis was also performed.
    Summary · context
    The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.
    Summary · context
    We randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet.
  6. 06HumanObservational studyMechanism

    In exenatide-treated women, higher weight loss at 3 months predicted super responder status, as it did with diet.

    In plain wordsIn exenatide-treated women, greater early weight loss was linked to super responder status, as it was with diet.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseEarly weight loss prediction of super response
    Study

    n: not reported in source

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In both treatment groups, higher weight loss at 3 months of treatment predicted super responder status (diet p=0.0098, exenatide p=0.0080).
    2 context sentences
    Summary · context
    The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.
    Summary · context
    We randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet.

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)

CompletedPhase 4Results postedNCT01590433

Weight Loss With Exenatide Treatment

Jody Dushayn = 249Mar 2012 to Jan 2019

Obesity

Trial pageClinicalTrials.govUpdated 23 Jun 2021

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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