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Study · Randomized controlled trial · n = 15 · 2017

8 results

Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.

Jensterle M, Kravos NA, Goričar K, Janez A

BMC endocrine disorders31 Jan 2017Cited by 58 (Europe PMC)

Summary

BackgroundLiraglutide 3 mg was recently approved as an anti-obesity drug. Metformin is weight neutral, yet it could enhance the therapeutic index of GLP-1 agonist. We compared weight-lowering potential of liraglutide 1.2 mg in combination with metformin to liraglutide 3 mg monotherapy in obese PCOS.MethodsThirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks. The primary outcome was change in anthropometric measures of obesity.ResultsBoth treatments led to significant weight loss (-3.6 ± 2.5 kg, p = 0.002 in COMBO vs -6.3 ± 3.7 kg, p = 0.001 in LIRA3). BMI and waist circumference reduction in LIRA3 was greater than in COMBO (-2.2 ± 1.3 vs -1.3 ± 0.9 kg/m2, p = 0.05 and -4.2 ± 3.4 vs -2.2 ± 6.2 cm, p = 0.014, respectively). Both interventions resulted in a significant decrease of post-OGTT glucose levels. COMBO significantly reduced total testosterone and was associated with less nausea.ConclusionsShort-term interventions with COMBO and LIRA3 both led to significant improvement of measures of obesity in obese PCOS, LIRA3 being superior to COMBO. However, COMBO further improved androgen profile beyond weight reduction and was associated with better tolerability.Trial registrationThe study was retrospectively registered with ClinicalTrials.gov ( NCT02909933 ) on 16th of September 2016.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In obese women with PCOS, liraglutide 3 mg once daily produced significant weight loss over 12 weeks.

    In plain wordsIn obese women with PCOS, liraglutide 3 mg once daily led to weight loss over 12 weeks.

    Outcome
    DecreaseWeight change at 12 weeks, liraglutide 3 mg
    Study

    n = 15

    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3 mg once daily · 12 weeksAs given in this study (human).

    Measurements

    Weight change
    −6.3 kg
    LIRA3

    Source sentences

    Summary
    Both treatments led to significant weight loss (-3.6 ± 2.5 kg, p = 0.002 in COMBO vs -6.3 ± 3.7 kg, p = 0.001 in LIRA3).
    1 context sentence
    Summary · context
    Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In obese women with PCOS, liraglutide 3 mg significantly decreased post-OGTT glucose levels.

    In plain wordsIn obese women with PCOS, liraglutide 3 mg lowered blood glucose after a glucose drink.

    Outcome
    DecreasePost-OGTT glucose, liraglutide 3 mg
    Study

    n = 15

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg once daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Both interventions resulted in a significant decrease of post-OGTT glucose levels.
    1 context sentence
    Summary · context
    Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks.

Studies that did not test the peptide alone6

In this study, Liraglutide 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 Liraglutide.

  1. 03HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In obese women with PCOS, liraglutide 3 mg reduced BMI more than metformin plus liraglutide 1.2 mg.

    In plain wordsIn obese women with PCOS, liraglutide 3 mg lowered BMI more than metformin plus a lower liraglutide dose.

    Outcome
    Not applicableBMI reduction, liraglutide 3 mg versus metformin plus liraglutide 1.2 mg
    Study

    n = 30

    Comparator
    Metformin plus liraglutide 1.2 mg
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    BMI change
    −2.2 kg/m2
    LIRA3
    BMI change
    −1.3 kg/m2
    COMBO

    Source sentences

    Summary
    BMI and waist circumference reduction in LIRA3 was greater than in COMBO (-2.2 ± 1.3 vs -1.3 ± 0.9 kg/m2, p = 0.05 and -4.2 ± 3.4 vs -2.2 ± 6.2 cm, p = 0.014, respectively).
    1 context sentence
    Summary · context
    Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks.

    In this study, Liraglutide 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 Liraglutide.

  2. 04HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In obese women with PCOS, liraglutide 3 mg reduced waist circumference more than metformin plus liraglutide 1.2 mg.

    In plain wordsIn obese women with PCOS, liraglutide 3 mg shrank the waist more than metformin plus a lower liraglutide dose.

    Outcome
    Not applicableWaist circumference reduction, liraglutide 3 mg versus metformin plus liraglutide 1.2 mg
    Study

    n = 30

    Comparator
    Metformin plus liraglutide 1.2 mg
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Waist circumference change
    −4.2 cm
    LIRA3
    Waist circumference change
    −2.2 cm
    COMBO

    Source sentences

    Summary
    BMI and waist circumference reduction in LIRA3 was greater than in COMBO (-2.2 ± 1.3 vs -1.3 ± 0.9 kg/m2, p = 0.05 and -4.2 ± 3.4 vs -2.2 ± 6.2 cm, p = 0.014, respectively).
    1 context sentence
    Summary · context
    Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks.

    In this study, Liraglutide 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 Liraglutide.

  3. 05HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In obese women with PCOS, metformin 1000 mg twice daily plus liraglutide 1.2 mg once daily produced significant weight loss over 12 weeks.

    In plain wordsIn obese women with PCOS, metformin plus liraglutide 1.2 mg led to weight loss over 12 weeks. The effect cannot be assigned to liraglutide alone.

    Outcome
    DecreaseWeight change at 12 weeks, metformin plus liraglutide 1.2 mg
    Study

    n = 15

    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Weight change
    −3.6 kg
    COMBO

    Source sentences

    Summary
    Both treatments led to significant weight loss (-3.6 ± 2.5 kg, p = 0.002 in COMBO vs -6.3 ± 3.7 kg, p = 0.001 in LIRA3).
    1 context sentence
    Summary · context
    Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks.

    In this study, Liraglutide 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 Liraglutide.

  4. 06HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome

    In obese women with PCOS, metformin plus liraglutide 1.2 mg was associated with less nausea than liraglutide 3 mg alone.

    In plain wordsIn obese women with PCOS, metformin plus liraglutide 1.2 mg was linked to less nausea than liraglutide 3 mg alone.

    Outcome
    DecreaseNausea, metformin plus liraglutide 1.2 mg versus liraglutide 3 mg
    Study

    n = 30

    Comparator
    Liraglutide 3 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Source sentences

    Summary
    was associated with less nausea.
    1 context sentence
    Summary · context
    Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks.

    In this study, Liraglutide 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 Liraglutide.

  5. 07HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In obese women with PCOS, metformin plus liraglutide 1.2 mg significantly decreased post-OGTT glucose levels.

    In plain wordsIn obese women with PCOS, metformin plus liraglutide 1.2 mg lowered blood glucose after a glucose drink. The effect cannot be assigned to liraglutide alone.

    Outcome
    DecreasePost-OGTT glucose, metformin plus liraglutide 1.2 mg
    Study

    n = 15

    Outcome group
    Glycemic control · Metabolic and weight

    Source sentences

    Summary
    Both interventions resulted in a significant decrease of post-OGTT glucose levels.
    1 context sentence
    Summary · context
    Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks.

    In this study, Liraglutide 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 Liraglutide.

  6. 08HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In obese women with PCOS, metformin plus liraglutide 1.2 mg significantly reduced total testosterone.

    In plain wordsIn obese women with PCOS, metformin plus liraglutide 1.2 mg lowered testosterone. The effect cannot be assigned to liraglutide alone.

    Outcome
    DecreaseTotal testosterone, metformin plus liraglutide 1.2 mg
    Study

    n = 15

    Outcome group
    Sex hormones and fertility · Endocrine and hormones

    Source sentences

    Summary
    COMBO significantly reduced total testosterone
    1 context sentence
    Summary · context
    Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m2) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks.

    In this study, Liraglutide 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 Liraglutide.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT03352869

Research of Exenatide for Overweight/Obese PCOS Patients With IGR

RenJi Hospitaln = 18328 Nov 2017 to 31 Jul 2018

Polycystic Ovary Syndrome · Overweight and Obesity · Disorder of Glucose Regulation

Trial pageClinicalTrials.govUpdated 11 Sept 2019
CompletedPhase 4NCT02909933

Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity

University Medical Centre Ljubljanan = 30Jul 2015 to Oct 2015

Polycystic Ovary Syndrome · Obesity

Trial pageClinicalTrials.govUpdated 21 Sept 2016

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, 12:10 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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