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Study · Randomized controlled trial · 2023

13 results

Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial.

Gerstein HC, Li Z, Ramasundarahettige C, Baek S, Branch KRH, Del Prato S, Lam CSP, Lopes RD, Pratley R, Rosenstock J, Sattar N

Circulation20 Feb 2023Cited by 20 (Europe PMC)

PMID36802715 (opens in a new tab)DOI10.1161/circulationaha.122.063716 (opens in a new tab)PepBankPUB-36802715
Publisher pagePubMedAsk about this study
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 6 mg reduced MACE versus placebo (6.2% versus 9.2%; HR 0.65, P=0.0027).

    In plain wordsIn people with diabetes, efpeglenatide 6 mg reduced major cardiovascular events compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseMACE
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    6 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Participants with MACE
    125 participants
    placebo
    Participants with MACE
    9.2%
    placebo
    Participants with MACE
    84 participants
    efpeglenatide 6 mg
    Participants with MACE
    6.2%
    efpeglenatide 6 mg
    Hazard ratio
    0.65 HR
    6 mg versus placebo
    Hazard ratio 95% CI
    0.5 to 0.86 HR
    6 mg versus placebo

    Source sentences

    Summary
    During a median follow-up of 1.8 years, MACE occurred in 125 (9.2%) participants assigned to placebo, 84 (6.2%) participants assigned to 6 mg of efpeglenatide (hazard ratio [HR], 0.65 [95% CI, 0.5-0.86]; P=0.0027), and 105 (7.7%) assigned to 4 mg of efpeglenatide (HR, 0.82 [95% CI, 0.63-1.06]; P=0.14).
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 4 mg did not significantly reduce MACE versus placebo (7.7% versus 9.2%; HR 0.82, P=0.14).

    In plain wordsIn people with diabetes, efpeglenatide 4 mg did not significantly reduce major cardiovascular events compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    No significant changeMACE
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    4 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Participants with MACE
    125 participants
    placebo
    Participants with MACE
    9.2%
    placebo
    Participants with MACE
    105 participants
    efpeglenatide 4 mg
    Participants with MACE
    7.7%
    efpeglenatide 4 mg
    Hazard ratio
    0.82 HR
    4 mg versus placebo
    Hazard ratio 95% CI
    0.63 to 1.06 HR
    4 mg versus placebo

    Source sentences

    Summary
    During a median follow-up of 1.8 years, MACE occurred in 125 (9.2%) participants assigned to placebo, 84 (6.2%) participants assigned to 6 mg of efpeglenatide (hazard ratio [HR], 0.65 [95% CI, 0.5-0.86]; P=0.0027), and 105 (7.7%) assigned to 4 mg of efpeglenatide (HR, 0.82 [95% CI, 0.63-1.06]; P=0.14).
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 6 mg reduced the expanded cardiovascular composite versus placebo (HR 0.73, P=0.011).

    In plain wordsIn people with diabetes, efpeglenatide 6 mg reduced the expanded cardiovascular composite compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseMACE, revascularization or unstable angina hospitalization
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    6 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.73 HR
    6 mg versus placebo

    Source sentences

    Summary
    Participants receiving high-dose efpeglenatide also experienced fewer secondary outcomes, including the composite of MACE, coronary revascularization, or hospitalization for unstable angina (HR, 0.73 for 6 mg, P=0.011; HR, 0.85 for 4 mg, P=0.17),
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 4 mg did not significantly reduce the expanded cardiovascular composite versus placebo (HR 0.85, P=0.17).

    In plain wordsIn people with diabetes, efpeglenatide 4 mg did not significantly reduce the expanded cardiovascular composite compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    No significant changeMACE, revascularization or unstable angina hospitalization
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    4 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.85 HR
    4 mg versus placebo

    Source sentences

    Summary
    Participants receiving high-dose efpeglenatide also experienced fewer secondary outcomes, including the composite of MACE, coronary revascularization, or hospitalization for unstable angina (HR, 0.73 for 6 mg, P=0.011; HR, 0.85 for 4 mg, P=0.17),
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 6 mg reduced the kidney composite versus placebo (HR 0.63, P<0.0001).

    In plain wordsIn people with diabetes, efpeglenatide 6 mg reduced the kidney composite compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseKidney composite
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    6 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.63 HR
    6 mg versus placebo

    Source sentences

    Summary
    a kidney composite outcome comprising sustained new macroalbuminuria, a ≥40% decline in estimated glomerular filtration rate or renal failure (HR, 0.63 for 6 mg, PP=0.0009),
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 4 mg reduced the kidney composite versus placebo (HR 0.73, P=0.0009).

    In plain wordsIn people with diabetes, efpeglenatide 4 mg reduced the kidney composite compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseKidney composite
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    4 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.73 HR
    4 mg versus placebo

    Source sentences

    Summary
    a kidney composite outcome comprising sustained new macroalbuminuria, a ≥40% decline in estimated glomerular filtration rate or renal failure (HR, 0.63 for 6 mg, PP=0.0009),
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 6 mg reduced MACE or any death versus placebo (HR 0.67, P=0.0021).

    In plain wordsIn people with diabetes, efpeglenatide 6 mg reduced cardiovascular events or death compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseMACE or any death
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    6 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.67 HR
    6 mg versus placebo

    Source sentences

    Summary
    MACE or any death (HR, 0.67 for 6 mg, P=0.0021; HR, 0.81 for 4 mg, P=0.08),
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 4 mg did not significantly reduce MACE or any death versus placebo (HR 0.81, P=0.08).

    In plain wordsIn people with diabetes, efpeglenatide 4 mg did not significantly reduce cardiovascular events or death compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    No significant changeMACE or any death
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    4 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.81 HR
    4 mg versus placebo

    Source sentences

    Summary
    MACE or any death (HR, 0.67 for 6 mg, P=0.0021; HR, 0.81 for 4 mg, P=0.08),
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 6 mg reduced the kidney function composite versus placebo (HR 0.61, P=0.0072).

    In plain wordsIn people with diabetes, efpeglenatide 6 mg reduced the kidney function composite compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseKidney function composite
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    6 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.61 HR
    6 mg versus placebo

    Source sentences

    Summary
    a kidney function outcome comprising a sustained ≥40% decline in estimated glomerular filtration rate, renal failure, or death (HR, 0.61 for 6 mg, P=0.0072; HR, 0.97 for 4 mg, P=0.83),
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 4 mg did not significantly reduce the kidney function composite versus placebo (HR 0.97, P=0.83).

    In plain wordsIn people with diabetes, efpeglenatide 4 mg did not significantly reduce the kidney function composite compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    No significant changeKidney function composite
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    4 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.97 HR
    4 mg versus placebo

    Source sentences

    Summary
    a kidney function outcome comprising a sustained ≥40% decline in estimated glomerular filtration rate, renal failure, or death (HR, 0.61 for 6 mg, P=0.0072; HR, 0.97 for 4 mg, P=0.83),
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 6 mg reduced the combined cardiovascular, death and kidney outcome versus placebo (HR 0.63, P=0.0002).

    In plain wordsIn people with diabetes, efpeglenatide 6 mg reduced the combined cardiovascular, death and kidney outcome compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseMACE, death, heart failure hospitalization or kidney function composite
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    6 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.63 HR
    6 mg versus placebo

    Source sentences

    Summary
    and the composite of MACE, any death, heart failure hospitalization, or the kidney function outcome (HR, 0.63 for 6 mg, P=0.0002; HR, 0.81 for 4 mg, P=0.067).
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  12. 12HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, efpeglenatide 4 mg did not significantly reduce the combined outcome versus placebo (HR 0.81, P=0.067).

    In plain wordsIn people with diabetes, efpeglenatide 4 mg did not significantly reduce the combined cardiovascular, death and kidney outcome compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    No significant changeMACE, death, heart failure hospitalization or kidney function composite
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    4 mg weekly · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    Hazard ratio
    0.81 HR
    4 mg versus placebo

    Source sentences

    Summary
    and the composite of MACE, any death, heart failure hospitalization, or the kidney function outcome (HR, 0.63 for 6 mg, P=0.0002; HR, 0.81 for 4 mg, P=0.067).
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.
  13. 13HumanRandomized controlled trialEfficacy outcome

    In people with diabetes, all primary and secondary outcomes showed a dose-response relationship with efpeglenatide (all P for trend ≤0.018).

    In plain wordsIn people with diabetes, efpeglenatide showed a dose-response relationship across the primary and secondary outcomes.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseOutcome dose-response trend
    Study

    n: not reported in source

    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    Dose not stated · median follow-up 1.8 yearsAs given in this study (human).

    Measurements

    P for trend
    ≤ 0.018
    dose-response across placebo, 4 mg and 6 mg, all primary and secondary outcomes

    Source sentences

    Summary
    A clear dose-response was noted for all primary and secondary outcomes (all P for trend ≤0.018).
    2 context sentences
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to placebo, 4 mg or 6 mg of efpeglenatide.
    Summary · context
    The effect of 6 mg versus placebo and of 4 mg versus placebo on MACE (a nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or unknown causes) and on all the secondary composite cardiovascular and kidney outcomes was assessed.

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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