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Study · Randomized controlled trial · n = 127 · 2022

7 results

Exenatide once weekly for alcohol use disorder investigated in a randomized, placebo-controlled clinical trial.

Klausen MK, Jensen ME, Møller M, Le Dous N, Jensen AØ, Zeeman VA, Johannsen CF, Lee A, Thomsen GK, Macoveanu J, Fisher PM, Gillum MP and 13 more

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Jørgensen NR, Bergmann ML, Enghusen Poulsen H, Becker U, Holst JJ, Benveniste H, Volkow ND, Vollstädt-Klein S, Miskowiak KW, Ekstrøm CT, Knudsen GM, Vilsbøll T, Fink-Jensen A

JCI insight10 Oct 2022Cited by 211 (Europe PMC)

PMID36066977 (opens in a new tab)PMCIDPMC9675448 (opens in a new tab)DOI10.1172/jci.insight.159863 (opens in a new tab)PepBankPUB-36066977
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Summary

BackgroundAlcohol use disorder (AUD) is a chronic, relapsing brain disorder that accounts for 5% of deaths annually, and there is an urgent need to develop new targets for therapeutic intervention. The glucagon-like peptide-1 (GLP-1) receptor agonist exenatide reduces alcohol consumption in rodents and nonhuman primates, but its efficacy in patients with AUD is unknown.MethodsIn a randomized, double-blinded, placebo-controlled clinical trial, treatment-seeking AUD patients were assigned to receive exenatide (2 mg subcutaneously) or placebo once weekly for 26 weeks, in addition to standard cognitive-behavioral therapy. The primary outcome was reduction in number of heavy drinking days. A subgroup also completed functional MRI (fMRI) and single-photon emission CT (SPECT) brain scans.ResultsA total of 127 patients were enrolled. Our data revealed that although exenatide did not significantly reduce the number of heavy drinking days compared with placebo, it significantly attenuated fMRI alcohol cue reactivity in the ventral striatum and septal area, which are crucial brain areas for drug reward and addiction. In addition, dopamine transporter availability was lower in the exenatide group compared with the placebo group. Exploratory analyses revealed that exenatide significantly reduced heavy drinking days and total alcohol intake in a subgroup of obese patients (BMI > 30 kg/m2). Adverse events were mainly gastrointestinal.ConclusionThis randomized controlled trial on the effects of a GLP-1 receptor agonist in AUD patients provides new important knowledge on the effects of GLP-1 receptor agonists as a novel treatment target in addiction.Trial registrationEudraCT: 2016-003343-11. ClinicalTrials.gov (NCT03232112).FundingNovavi Foundation; Research Foundation, Mental Health Services, Capital Region of Denmark; Research Foundation, Capital Region of Denmark; Ivan Nielsen Foundation; A.P. Moeller Foundation; Augustinus Foundation; Woerzner Foundation; Grosserer L.F. Foghts Foundation; Hartmann Foundation; Aase and Ejnar Danielsen Foundation; P.A. Messerschmidt and Wife Foundation; and Lundbeck Foundation.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with alcohol use disorder, exenatide did not significantly reduce heavy drinking days versus placebo.

    In plain wordsExenatide did not significantly reduce heavy drinking days compared with placebo in patients with alcohol use disorder.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeHeavy drinking days
    Study

    n = 127

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    2 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Our data revealed that although exenatide did not significantly reduce the number of heavy drinking days compared with placebo,
    1 context sentence
    Summary · context
    MethodsIn a randomized, double-blinded, placebo-controlled clinical trial, treatment-seeking AUD patients were assigned to receive exenatide (2 mg subcutaneously) or placebo once weekly for 26 weeks, in addition to standard cognitive-behavioral therapy.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with alcohol use disorder and obesity, exenatide reduced heavy drinking days versus placebo in exploratory analyses.

    In plain wordsExenatide reduced heavy drinking days compared with placebo in an exploratory subgroup of patients with obesity.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHeavy drinking days in obesity subgroup
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    2 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Exploratory analyses revealed that exenatide significantly reduced heavy drinking days and total alcohol intake in a subgroup of obese patients (BMI > 30 kg/m2).
    1 context sentence
    Summary · context
    MethodsIn a randomized, double-blinded, placebo-controlled clinical trial, treatment-seeking AUD patients were assigned to receive exenatide (2 mg subcutaneously) or placebo once weekly for 26 weeks, in addition to standard cognitive-behavioral therapy.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with alcohol use disorder and obesity, exenatide reduced total alcohol intake versus placebo in exploratory analyses.

    In plain wordsExenatide reduced total alcohol intake compared with placebo in an exploratory subgroup of patients with obesity.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseTotal alcohol intake in obesity subgroup
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Addiction, withdrawal and alcohol intake · Mental health and mood
    Studied dose
    2 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Exploratory analyses revealed that exenatide significantly reduced heavy drinking days and total alcohol intake in a subgroup of obese patients (BMI > 30 kg/m2).
    1 context sentence
    Summary · context
    MethodsIn a randomized, double-blinded, placebo-controlled clinical trial, treatment-seeking AUD patients were assigned to receive exenatide (2 mg subcutaneously) or placebo once weekly for 26 weeks, in addition to standard cognitive-behavioral therapy.
  4. 04HumanRandomized controlled trialMechanism

    In patients with alcohol use disorder, exenatide attenuated ventral striatal alcohol cue reactivity versus placebo.

    In plain wordsExenatide reduced alcohol cue responses in one reward-related brain area compared with placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseVentral striatal alcohol cue reactivity
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    2 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    it significantly attenuated fMRI alcohol cue reactivity in the ventral striatum and septal area, which are crucial brain areas for drug reward and addiction.
    1 context sentence
    Summary · context
    MethodsIn a randomized, double-blinded, placebo-controlled clinical trial, treatment-seeking AUD patients were assigned to receive exenatide (2 mg subcutaneously) or placebo once weekly for 26 weeks, in addition to standard cognitive-behavioral therapy.
  5. 05HumanRandomized controlled trialMechanism

    In patients with alcohol use disorder, exenatide attenuated septal alcohol cue reactivity versus placebo.

    In plain wordsExenatide reduced alcohol cue responses in the septal brain area compared with placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseSeptal alcohol cue reactivity
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    2 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    it significantly attenuated fMRI alcohol cue reactivity in the ventral striatum and septal area, which are crucial brain areas for drug reward and addiction.
    1 context sentence
    Summary · context
    MethodsIn a randomized, double-blinded, placebo-controlled clinical trial, treatment-seeking AUD patients were assigned to receive exenatide (2 mg subcutaneously) or placebo once weekly for 26 weeks, in addition to standard cognitive-behavioral therapy.
  6. 06HumanRandomized controlled trialMechanism

    In patients with alcohol use disorder, dopamine transporter availability was lower with exenatide than placebo.

    In plain wordsDopamine transporter availability was lower with exenatide than with placebo in patients with alcohol use disorder.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseDopamine transporter availability
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    2 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    In addition, dopamine transporter availability was lower in the exenatide group compared with the placebo group.
    1 context sentence
    Summary · context
    MethodsIn a randomized, double-blinded, placebo-controlled clinical trial, treatment-seeking AUD patients were assigned to receive exenatide (2 mg subcutaneously) or placebo once weekly for 26 weeks, in addition to standard cognitive-behavioral therapy.

Studies that did not test the peptide alone1

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

  1. 07HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome

    In the exenatide trial in alcohol use disorder, adverse events were mainly gastrointestinal.

    In plain wordsAdverse events were mainly digestive in the exenatide trial for alcohol use disorder.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Direction not reportedGastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Source sentences

    Summary
    Adverse events were mainly gastrointestinal.
    1 context sentence
    Summary · context
    MethodsIn a randomized, double-blinded, placebo-controlled clinical trial, treatment-seeking AUD patients were assigned to receive exenatide (2 mg subcutaneously) or placebo once weekly for 26 weeks, in addition to standard cognitive-behavioral therapy.

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT03232112

Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence?

Anders Fink-Jensen, MD, DMScin = 1527 Aug 2017 to 5 Oct 2020

Alcohol Dependence, in Remission · Addiction, Alcohol

Trial pageClinicalTrials.govUpdated 4 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.

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