Short term monotherapy with GLP-1 receptor agonist liraglutide or PDE 4 inhibitor roflumilast is superior to metformin in weight loss in obese PCOS women: a pilot randomized study.

Jensterle M, Salamun V, Kocjan T, Vrtacnik Bokal E, Janez A

Journal of ovarian research2 Jun 2015Cited by 83 (Europe PMC)

PMID26032655PMCIDPMC4506413DOI10.1186/s13048-015-0161-3PepBankPUB-26032655

Summary

ObjectiveTo evaluate whether liraglutide or roflumilast significantly affects body weight when compared to metformin in obese women with PCOS.Design/main outcome measureA 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria. They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD. The primary outcome was change in measures of obesity.ResultsForty-one patients (aged 30.7 ± 7.9 years, BMI 38.6 ± 6.0 kg/m2, mean ± SD) completed the study. Subjects treated with LIRA lost on average 3.1 ± 3.5 kg (p = 0.006), on ROF 2.1 ± 2.0 kg (p = 0.002) vs. 0.2 ± 1.83 kg in MET group. BMI decreased for 1.1 ± 1.26 kg/m2 in LIRA (p = 0.006), for 0.8 ± 0.99 kg/m2 in ROF (p = 0.001) vs. 0.1 ± 0.67 kg/m2 in MET. LIRA was superior to MET in reducing weight (p = 0.022), BMI (p = 0.020), waist circumference (p = 0.007). LIRA also resulted in decrease in VAT area (p = 0.015) and more favorable dynamics in glucose homeostasis during OGTT. ROF resulted in reduction of waist circumference (p = 0.023). In addition, ROF led to testosterone reduction (p = 0.05) and increase in menstrual frequencies (p = 0.009) when compared to baseline.ConclusionShort-term monotherapy with liraglutide or roflumilast was associated with significant weight loss in obese PCOS. Liraglutide was superior to metformin, whereas roflumilast resulted in greater, yet not statistically significant, mean weight loss when compared to metformin. Reduction of body weight with liraglutide resulted in improvement of body composition.Trial registrationClinicalTrials.gov NCT02187250 .

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In obese women with PCOS, liraglutide reduced body weight by 3.1 kg on average over 12 weeks, compared with a change of 0.2 kg with metformin.
In plain wordsIn obese women with PCOS, liraglutide lowered body weight by about 3.1 kg in 12 weeks, compared with metformin.
Peptide
Liraglutide
Outcome
DecreaseBody weight change
Study
n: not reported in source
Comparator
Metformin
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · subcutaneous · 12 weeksAs given in this study (human).
Measurements
weight loss
3.1 kg
liraglutide
Source sentences
Summary
Subjects treated with LIRA lost on average 3.1 ± 3.5 kg (p = 0.006), on ROF 2.1 ± 2.0 kg (p = 0.002) vs. 0.2 ± 1.83 kg in MET group.
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria.
Summary · context
They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD.
Show in the study text Report a problemFND-2603265501
02HumanRandomized controlled trialEfficacy outcome
In obese women with PCOS, liraglutide decreased BMI by 1.1 kg/m2, compared with a change of 0.1 kg/m2 with metformin.
In plain wordsIn obese women with PCOS, liraglutide lowered BMI more than metformin did over 12 weeks.
Peptide
Liraglutide
Outcome
DecreaseBMI change
Study
n: not reported in source
Comparator
Metformin
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · subcutaneous · 12 weeksAs given in this study (human).
Measurements
BMI decrease
1.1 kg/m2
liraglutide
Source sentences
Summary
BMI decreased for 1.1 ± 1.26 kg/m2 in LIRA (p = 0.006), for 0.8 ± 0.99 kg/m2 in ROF (p = 0.001) vs. 0.1 ± 0.67 kg/m2 in MET.
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria.
Summary · context
They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD.
Show in the study text Report a problemFND-2603265502
03HumanRandomized controlled trialEfficacy outcome
In obese women with PCOS, liraglutide was superior to metformin in reducing body weight.
In plain wordsIn obese women with PCOS, liraglutide reduced weight more than metformin did.
Peptide
Liraglutide
Outcome
DecreaseBody weight reduction versus metformin
Study
n: not reported in source
Comparator
Metformin
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
LIRA was superior to MET in reducing weight (p = 0.022), BMI (p = 0.020), waist circumference (p = 0.007).
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria.
Summary · context
They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD.
Show in the study text Report a problemFND-2603265503
04HumanRandomized controlled trialEfficacy outcome
In obese women with PCOS, liraglutide was superior to metformin in reducing BMI.
In plain wordsIn obese women with PCOS, liraglutide reduced BMI more than metformin did.
Peptide
Liraglutide
Outcome
DecreaseBMI reduction versus metformin
Study
n: not reported in source
Comparator
Metformin
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
LIRA was superior to MET in reducing weight (p = 0.022), BMI (p = 0.020), waist circumference (p = 0.007).
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria.
Summary · context
They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD.
Show in the study text Report a problemFND-2603265504
05HumanRandomized controlled trialEfficacy outcome
In obese women with PCOS, liraglutide was superior to metformin in reducing waist circumference.
In plain wordsIn obese women with PCOS, liraglutide reduced waist size more than metformin did.
Peptide
Liraglutide
Outcome
DecreaseWaist circumference reduction versus metformin
Study
n: not reported in source
Comparator
Metformin
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
LIRA was superior to MET in reducing weight (p = 0.022), BMI (p = 0.020), waist circumference (p = 0.007).
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria.
Summary · context
They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD.
Show in the study text Report a problemFND-2603265505
06HumanRandomized controlled trialEfficacy outcome
In obese women with PCOS, liraglutide decreased visceral adipose tissue (VAT) area.
In plain wordsIn obese women with PCOS, liraglutide reduced the area of belly (visceral) fat.
Peptide
Liraglutide
Outcome
DecreaseVisceral adipose tissue (VAT) area
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg once daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
LIRA also resulted in decrease in VAT area (p = 0.015) and more favorable dynamics in glucose homeostasis during OGTT.
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria.
Summary · context
They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD.
Show in the study text Report a problemFND-2603265506
07HumanRandomized controlled trialEfficacy outcome
In obese women with PCOS, liraglutide gave more favorable dynamics in glucose homeostasis during the oral glucose tolerance test (OGTT).
In plain wordsIn obese women with PCOS, liraglutide led to more favorable blood sugar handling during a glucose tolerance test.
Peptide
Liraglutide
Outcome
Direction not reportedGlucose homeostasis during OGTT
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.2 mg once daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
LIRA also resulted in decrease in VAT area (p = 0.015) and more favorable dynamics in glucose homeostasis during OGTT.
2 context sentences(design, population, supporting numbers)
Summary · context
A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria.
Summary · context
They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD.
Show in the study text Report a problemFND-2603265507

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 4NCT02187250

PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

University Medical Centre Ljubljanan = 45Mar 2014 to Jun 2014

PCOS · Obesity

Trial page ClinicalTrials.govUpdated 10 Jul 2014

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.

Version 2Current
12 Oct 2026, 12:10 UTC
Study results updated
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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MeSH terms

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