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Study · Randomized controlled trial · 2022

6 results

Efficacy and safety of efpeglenatide in key patient subgroups from the BALANCE randomized trial, stratified by pre-diabetes status, BMI, and age at baseline.

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

BMJ open diabetes research & care1 Jan 2022Cited by 8 (Europe PMC)

PMID35042751 (opens in a new tab)PMCIDPMC8768911 (opens in a new tab)DOI10.1136/bmjdrc-2021-002207 (opens in a new tab)PepBankPUB-35042751
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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 study6

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In participants with pre-diabetes, efpeglenatide increased reversion to normoglycemia versus placebo (40.6%-64.3% versus 10.0%; nominal p<0.05).

    In plain wordsIn participants with pre-diabetes, efpeglenatide increased the proportion returning to normal glucose levels compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    IncreaseReversion to normoglycemia
    Study

    n: not reported in source

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

    Measurements

    Reverted to normoglycemia
    40.6 to 64.3%
    efpeglenatide doses, pre-diabetes subgroup
    Reverted to normoglycemia
    10%
    placebo, pre-diabetes subgroup

    Source sentences

    Summary
    In patients with pre-diabetes at baseline, all efpeglenatide doses led to greater proportions of patients reverting to normoglycemia (40.6%-64.3%) versus placebo (10.0%), and greater reductions in HbA1c (0.30%-0.38%), FPG (7.7-14.1 mg/dL), and weight (5.6-7.3 kg) versus placebo (nominal p<0.05 for all).
    1 context sentence
    Summary · context
    The 20-week BALANCE study randomized patients with BMI ≥30 kg/m2 or ≥27 kg/m2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In participants with pre-diabetes, efpeglenatide doses produced greater HbA1c reductions than placebo (0.30%-0.38%; nominal p<0.05).

    In plain wordsIn participants with pre-diabetes, efpeglenatide reduced HbA1c more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseHbA1c in pre-diabetes
    Study

    n: not reported in source

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

    Measurements

    HbA1c reduction
    0.3 to 0.38%
    pre-diabetes subgroup, efpeglenatide doses versus placebo

    Source sentences

    Summary
    In patients with pre-diabetes at baseline, all efpeglenatide doses led to greater proportions of patients reverting to normoglycemia (40.6%-64.3%) versus placebo (10.0%), and greater reductions in HbA1c (0.30%-0.38%), FPG (7.7-14.1 mg/dL), and weight (5.6-7.3 kg) versus placebo (nominal p<0.05 for all).
    1 context sentence
    Summary · context
    The 20-week BALANCE study randomized patients with BMI ≥30 kg/m2 or ≥27 kg/m2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In participants with pre-diabetes, efpeglenatide doses produced greater FPG reductions than placebo (7.7-14.1 mg/dL; nominal p<0.05).

    In plain wordsIn participants with pre-diabetes, efpeglenatide reduced fasting glucose more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseFasting plasma glucose in pre-diabetes
    Study

    n: not reported in source

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

    Measurements

    Fasting plasma glucose reduction
    7.7 to 14.1 mg/dL
    pre-diabetes subgroup, efpeglenatide doses versus placebo

    Source sentences

    Summary
    In patients with pre-diabetes at baseline, all efpeglenatide doses led to greater proportions of patients reverting to normoglycemia (40.6%-64.3%) versus placebo (10.0%), and greater reductions in HbA1c (0.30%-0.38%), FPG (7.7-14.1 mg/dL), and weight (5.6-7.3 kg) versus placebo (nominal p<0.05 for all).
    1 context sentence
    Summary · context
    The 20-week BALANCE study randomized patients with BMI ≥30 kg/m2 or ≥27 kg/m2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In participants with pre-diabetes, efpeglenatide doses produced greater weight reductions than placebo (5.6-7.3 kg; nominal p<0.05).

    In plain wordsIn participants with pre-diabetes, efpeglenatide reduced weight more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseBody weight in pre-diabetes
    Study

    n: not reported in source

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

    Measurements

    Weight reduction
    5.6 to 7.3 kg
    pre-diabetes subgroup, efpeglenatide doses versus placebo

    Source sentences

    Summary
    In patients with pre-diabetes at baseline, all efpeglenatide doses led to greater proportions of patients reverting to normoglycemia (40.6%-64.3%) versus placebo (10.0%), and greater reductions in HbA1c (0.30%-0.38%), FPG (7.7-14.1 mg/dL), and weight (5.6-7.3 kg) versus placebo (nominal p<0.05 for all).
    1 context sentence
    Summary · context
    The 20-week BALANCE study randomized patients with BMI ≥30 kg/m2 or ≥27 kg/m2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In participants stratified by median BMI or median age, all efpeglenatide doses reduced weight more than placebo (nominal p<0.01 for all).

    In plain wordsIn participants split by median BMI or median age, all efpeglenatide doses reduced weight more than placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseBody weight across BMI and age subgroups
    Study

    n: not reported in source

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

    Source sentences

    Summary
    In patients with BMI or age < or ≥ median, greater reductions in weight were observed with all efpeglenatide doses versus placebo (nominal p<0.01 for all).
    1 context sentence
    Summary · context
    The 20-week BALANCE study randomized patients with BMI ≥30 kg/m2 or ≥27 kg/m2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo.
  6. 06HumanRandomized controlled trialSafety outcome

    Across patient subgroups, gastrointestinal adverse events were the most common adverse events with efpeglenatide.

    In plain wordsAcross patient subgroups, digestive adverse events were the most common adverse events with efpeglenatide.

    Peptide
    Efpeglenatide
    Outcome
    Direction not reportedGastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 20 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events in patients receiving efpeglenatide across patient subgroups were gastrointestinal adverse events.
    1 context sentence
    Summary · context
    The 20-week BALANCE study randomized patients with BMI ≥30 kg/m2 or ≥27 kg/m2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo.

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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