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Study · Randomized controlled trial · n = 30 · 2021

6 results

Effect of 26 Weeks of Liraglutide Treatment on Coronary Artery Inflammation in Type 2 Diabetes Quantified by [64Cu]Cu-DOTATATE PET/CT: Results from the LIRAFLAME Trial.

Jensen JK, Zobel EH, von Scholten BJ, Rotbain Curovic V, Hansen TW, Rossing P, Kjaer A, Ripa RS

Frontiers in endocrinology30 Nov 2021Cited by 38 (Europe PMC)

Summary

BackgroundQuantification of coronary artery inflammation and atherosclerosis remains a challenge in high-risk individuals. In this study we sought to investigate if the glucagon like peptide-1 receptor agonist liraglutide has a direct anti-inflammatory effect in the coronary arteries using positron emission tomography (PET) with a radioactive tracer targeting activated macrophages in the vessel-wall.MethodsThirty randomly selected participants with type 2 diabetes from the placebo-controlled trial LIRAFLAME were enrolled in this sub-study. Participants were, prior to enrollment in this sub-study, randomized to either treatment with daily liraglutide (n=15) or placebo (n=15). Both groups underwent a combined [64Cu]Cu-DOTATATE positron emission tomography and computed tomography scan of the heart at baseline and after 26 weeks of treatment. Coronary artery uptake of [64Cu]Cu-DOTATATE were measured as maximum standardized uptake values (SUVmax); and means of the maximum values (mSUVmax), both values were calculated at the level of each participant and each individual coronary-segment.ResultsSUVmax and mSUVmax values decreased significantly in the liraglutide group both at the participant level (SUVmax: p=0.013; mSUVmax: p=0.004) and at the coronary-segment level (SUVmax: p=0.001; mSUVmax: p<0.0001). No change was observed in the placebo group neither at the participant level (SUVmax: p=0.69; mSUVmax: p=0.67) or at the coronary-segment level (SUVmax: p=0.49; mSUVmax: p=0.30). When comparing the mean change in uptake values between the two groups at both the participant level (SUVmax: p=0.076; mSUVmax: p=0.077) and the coronary segment level (SUVmax: p=0.13; mSUVmax: p=0.11) a borderline significant difference was observed. Baseline SUVmax [64Cu]Cu-DOTATATE uptake values showed a weak positive correlation with the inflammatory biomarker high-sensitivity c-reactive protein (τ =0.26, p=0.045).ConclusionLiraglutide treatment for 26-weeks caused a significant reduction in [64Cu]Cu-DOTATATE uptake in the coronary arteries whereas this was not seen in the placebo treated group. In addition, [64Cu]Cu-DOTATATE PET/CT as a marker of coronary inflammation correlated with the systemic inflammation marker hs-CRP.
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 adults with type 2 diabetes, the difference in mean change in coronary tracer uptake between liraglutide and placebo at participant level was borderline and not significant.

    In plain wordsIn adults with type 2 diabetes, the drop in heart artery inflammation signal with liraglutide was only borderline different from placebo.

    Outcome
    No significant changeCoronary SUVmax and mSUVmax change, participant level, liraglutide versus placebo
    Study

    n = 30

    Comparator
    Placebo
    Outcome group
    Inflammation markers · Cardiovascular
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    SUVmax p value
    0.076
    participant level
    mSUVmax p value
    0.077
    participant level

    Source sentences

    Summary
    When comparing the mean change in uptake values between the two groups at both the participant level (SUVmax: p=0.076; mSUVmax: p=0.077) and the coronary segment level (SUVmax: p=0.13; mSUVmax: p=0.11) a borderline significant difference was observed.
    1 context sentence
    Summary · context
    Participants were, prior to enrollment in this sub-study, randomized to either treatment with daily liraglutide (n=15) or placebo (n=15).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, the difference in mean change in coronary tracer uptake between liraglutide and placebo at coronary-segment level was borderline and not significant.

    In plain wordsIn adults with type 2 diabetes, the drop in inflammation signal in heart artery segments with liraglutide was only borderline different from placebo.

    Outcome
    No significant changeCoronary SUVmax and mSUVmax change, segment level, liraglutide versus placebo
    Study

    n = 30

    Comparator
    Placebo
    Outcome group
    Inflammation markers · Cardiovascular
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    SUVmax p value
    0.13
    segment level
    mSUVmax p value
    0.11
    segment level

    Source sentences

    Summary
    When comparing the mean change in uptake values between the two groups at both the participant level (SUVmax: p=0.076; mSUVmax: p=0.077) and the coronary segment level (SUVmax: p=0.13; mSUVmax: p=0.11) a borderline significant difference was observed.
    1 context sentence
    Summary · context
    Participants were, prior to enrollment in this sub-study, randomized to either treatment with daily liraglutide (n=15) or placebo (n=15).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, coronary artery uptake of the macrophage PET tracer (SUVmax) fell significantly at participant level in the liraglutide group.

    In plain wordsIn adults with type 2 diabetes, liraglutide for 26 weeks was followed by lower heart artery inflammation signal on PET scans.

    Outcome
    DecreaseCoronary SUVmax, participant level, within liraglutide group
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Inflammation markers · Cardiovascular
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    SUVmax p value
    0.013
    participant level

    Source sentences

    Summary
    SUVmax and mSUVmax values decreased significantly in the liraglutide group both at the participant level (SUVmax: p=0.013; mSUVmax: p=0.004) and at the coronary-segment level (SUVmax: p=0.001; mSUVmax: p<0.0001).
    1 context sentence
    Summary · context
    Participants were, prior to enrollment in this sub-study, randomized to either treatment with daily liraglutide (n=15) or placebo (n=15).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, mean coronary artery uptake of the macrophage PET tracer (mSUVmax) fell significantly at participant level in the liraglutide group.

    In plain wordsIn adults with type 2 diabetes, liraglutide for 26 weeks was followed by lower average heart artery inflammation signal on PET scans.

    Outcome
    DecreaseCoronary mSUVmax, participant level, within liraglutide group
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Inflammation markers · Cardiovascular
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    mSUVmax p value
    0.004
    participant level

    Source sentences

    Summary
    SUVmax and mSUVmax values decreased significantly in the liraglutide group both at the participant level (SUVmax: p=0.013; mSUVmax: p=0.004) and at the coronary-segment level (SUVmax: p=0.001; mSUVmax: p<0.0001).
    1 context sentence
    Summary · context
    Participants were, prior to enrollment in this sub-study, randomized to either treatment with daily liraglutide (n=15) or placebo (n=15).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, coronary artery uptake of the macrophage PET tracer (SUVmax) fell significantly at coronary-segment level in the liraglutide group.

    In plain wordsIn adults with type 2 diabetes, liraglutide for 26 weeks was followed by lower inflammation signal in individual heart artery segments.

    Outcome
    DecreaseCoronary SUVmax, segment level, within liraglutide group
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Inflammation markers · Cardiovascular
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    SUVmax p value
    0.001
    segment level

    Source sentences

    Summary
    SUVmax and mSUVmax values decreased significantly in the liraglutide group both at the participant level (SUVmax: p=0.013; mSUVmax: p=0.004) and at the coronary-segment level (SUVmax: p=0.001; mSUVmax: p<0.0001).
    1 context sentence
    Summary · context
    Participants were, prior to enrollment in this sub-study, randomized to either treatment with daily liraglutide (n=15) or placebo (n=15).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, mean coronary artery uptake of the macrophage PET tracer (mSUVmax) fell significantly at coronary-segment level in the liraglutide group.

    In plain wordsIn adults with type 2 diabetes, liraglutide for 26 weeks was followed by lower average inflammation signal in individual heart artery segments.

    Outcome
    DecreaseCoronary mSUVmax, segment level, within liraglutide group
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Inflammation markers · Cardiovascular
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    SUVmax and mSUVmax values decreased significantly in the liraglutide group both at the participant level (SUVmax: p=0.013; mSUVmax: p=0.004) and at the coronary-segment level (SUVmax: p=0.001; mSUVmax: p<0.0001).
    1 context sentence
    Summary · context
    Participants were, prior to enrollment in this sub-study, randomized to either treatment with daily liraglutide (n=15) or placebo (n=15).

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

    12 Oct 2026, 11:11 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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