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Study · Randomized controlled trial · 2019

9 results

Body weight management and safety with efpeglenatide in adults without diabetes: A phase II randomized study.

Pratley RE, Kang J, Trautmann ME, Hompesch M, Han O, Stewart J, Sorli CH, Jacob S, Yoon KH

Diabetes, obesity & metabolism13 Aug 2019Cited by 40 (Europe PMC)

PMID31264757 (opens in a new tab)PMCIDPMC6851541 (opens in a new tab)DOI10.1111/dom.13824 (opens in a new tab)PepBankPUB-31264757
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults without diabetes, efpeglenatide reduced body weight from baseline versus placebo over 20 weeks, with placebo-adjusted changes from -6.3 kg to -7.2 kg across doses (P<0.0001).

    In plain wordsIn adults without diabetes, efpeglenatide reduced weight more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseBody weight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Measurements

    Placebo-adjusted body weight change
    −6.3 kg
    6 mg once every 2 wk, 20 wk
    Placebo-adjusted body weight change
    −7.2 kg
    6 mg once weekly, 20 wk

    Source sentences

    Summary
    Over 20 wk, all doses of efpeglenatide significantly reduced body weight from baseline versus placebo (P < 0.0001), with placebo-adjusted reductions ranging between -6.3 kg (6 mg once every 2 wk) and -7.2 kg (6 mg once weekly).
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults without diabetes, more efpeglenatide recipients lost ≥5% of body weight than placebo recipients (P<0.01).

    In plain wordsIn adults without diabetes, more efpeglenatide recipients lost at least 5% of body weight than placebo recipients.

    Peptide
    Efpeglenatide
    Outcome
    IncreaseWeight loss of at least 5%
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Source sentences

    Summary
    Greater proportions of efpeglenatide-treated participants had body weight loss of ≥5% or ≥10% versus placebo (P < 0.01, all comparisons).
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults without diabetes, more efpeglenatide recipients lost ≥10% of body weight than placebo recipients (P<0.01).

    In plain wordsIn adults without diabetes, more efpeglenatide recipients lost at least 10% of body weight than placebo recipients.

    Peptide
    Efpeglenatide
    Outcome
    IncreaseWeight loss of at least 10%
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Source sentences

    Summary
    Greater proportions of efpeglenatide-treated participants had body weight loss of ≥5% or ≥10% versus placebo (P < 0.01, all comparisons).
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults without diabetes, efpeglenatide significantly improved fasting plasma glucose versus placebo.

    In plain wordsIn adults without diabetes, efpeglenatide improved fasting glucose compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    Direction not reportedFasting plasma glucose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Source sentences

    Summary
    Efpeglenatide led to significant improvements in glycaemic variables (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) versus placebo.
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults without diabetes, efpeglenatide significantly improved glycated haemoglobin versus placebo.

    In plain wordsIn adults without diabetes, efpeglenatide improved HbA1c compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    Direction not reportedHbA1c
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Source sentences

    Summary
    Efpeglenatide led to significant improvements in glycaemic variables (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) versus placebo.
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults without diabetes, efpeglenatide significantly improved cholesterol versus placebo.

    In plain wordsIn adults without diabetes, efpeglenatide improved cholesterol compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    Direction not reportedCholesterol
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Source sentences

    Summary
    Efpeglenatide led to significant improvements in glycaemic variables (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) versus placebo.
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults without diabetes, efpeglenatide significantly improved triglycerides versus placebo.

    In plain wordsIn adults without diabetes, efpeglenatide improved triglycerides compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    Direction not reportedTriglycerides
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Source sentences

    Summary
    Efpeglenatide led to significant improvements in glycaemic variables (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) versus placebo.
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
  8. 08HumanRandomized controlled trialSafety outcome

    In adults without diabetes, adverse events caused study discontinuation in 5% to 19% of efpeglenatide recipients.

    In plain wordsIn adults without diabetes, adverse events caused 5% to 19% of efpeglenatide recipients to stop the study.

    Peptide
    Efpeglenatide
    Outcome
    Direction not reportedDiscontinuation due to adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Measurements

    Discontinuation due to adverse events
    5 to 19%
    efpeglenatide-treated participants

    Source sentences

    Summary
    Rates of study discontinuations as a result of adverse events ranged from 5% to 19% with efpeglenatide.
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.
  9. 09HumanRandomized controlled trialSafety outcome

    In adults without diabetes, gastrointestinal effects were the most common treatment-emergent adverse events with efpeglenatide.

    In plain wordsIn adults without diabetes, digestive effects were the most common adverse events during efpeglenatide treatment.

    Peptide
    Efpeglenatide
    Outcome
    Direction not reportedGastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk · 20 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal effects were the most common treatment-emergent adverse events.
    3 context sentences
    Summary · context
    were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.
    Summary · context
    participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity
    Summary · context
    The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates.

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.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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