What are the benefits of GLP-1 inhibitors in patients with polycystic ovarian syndrome?

Comment by InpharmD Researcher

A moderate body of evidence suggests that glucagon-like peptide-1 (GLP-1) receptor agonists may benefit women with polycystic ovary syndrome (PCOS), particularly those who are overweight or have obesity. Current international PCOS guideline recommendations support their use as an adjunct to lifestyle intervention for management of higher weight while acknowledging the lack of long-term safety data. Consistent with these recommendations, multiple meta-analyses have demonstrated reductions in body weight, body mass index, and waist circumference. However, evidence for metabolic, reproductive, hormonal, and psychological outcomes remains limited, with more recent evidence indicating that these benefits remain uncertain. Gastrointestinal adverse effects are the most commonly reported treatment-related events and are generally mild to moderate.

Background

According to the 2023 international evidence-based guideline for polycystic ovary syndrome (PCOS), anti-obesity medications, including the glucagon-like peptide-1 (GLP-1) receptor agonists liraglutide and semaglutide, could be considered in addition to active lifestyle intervention for management of higher weight in adults with PCOS, consistent with general population obesity guidelines. Effective contraception is recommended when pregnancy is possible, as pregnancy safety data are lacking, and gradual dose escalation is advised to reduce gastrointestinal adverse effects. Shared decision-making should include discussion of potential side effects, the possible need for long-term therapy for weight management, the risk of weight regain after discontinuation, and the lack of long-term safety data. Anti-obesity agents are recommended for reproductive outcomes only in research settings until efficacy and safety are established. These recommendations were informed by a meta-analysis of 11 trials evaluating anti-obesity agents in PCOS, in which liraglutide, semaglutide, and orlistat appeared superior to placebo for anthropometric outcomes; however, evidence for hormonal, reproductive, metabolic, and psychological outcomes was limited, highlighting the need for further research. [1], [2]

A recent meta-analysis included 11 randomized controlled trials (RCTs) evaluating GLP-1 receptor agonists in women with PCOS. Compared with control, GLP-1 receptor agonists as add-on therapy were associated with a reduction in body mass index (mean difference [MD] −1.38 kg/m²; 95% confidence interval [CI] −2.39 to −0.38; low-certainty evidence). No differences were observed for low-density lipoprotein cholesterol or triglycerides, and evidence was insufficient to draw conclusions regarding glucose, insulin, hirsutism, or menstrual regularity. No studies evaluated quality of life, mental health, or cost-effectiveness. The authors concluded that GLP-1 receptor agonists are associated with modest short-term weight loss in women with PCOS and overweight or obesity; however, evidence for metabolic, reproductive, and psychological outcomes remains uncertain due to low-quality data. [3]

A 2024 meta-analysis of four RCTs involving 176 participants evaluated the efficacy and safety of GLP-1 receptor agonists (GLP-1 RAs) in women with PCOS and obesity. Compared to placebo, GLP-1 RA treatment resulted in a significant reduction in waist circumference (MD -5.16 cm; 95% CI -6.11 to -4.21; p<0.00001) and body mass index (BMI; MD -2.42; 95% CI -3.10 to -1.74; p<0.00001). Treatment also significantly lowered serum triglycerides (MD -0.20 mmol/L) and total testosterone levels (MD -1.33 nmol/L). However, no significant differences were found for total cholesterol (MD -0.04 mmol/L) or HOMA-IR (MD -0.30). Adverse events, primarily mild gastrointestinal symptoms, were more common with GLP-1 RAs (49 out of 112 patients) compared to placebo (9 out of 60), but led to only two treatment discontinuations. The results suggest that GLP-1 RAs are an effective intervention for reducing weight, improving lipid profiles, and lowering androgen levels in this patient population. [4]

Another 2021 review discusses the clinical potential of exenatide and liraglutide, particularly for overweight or obese PCOS women, and those with glucose intolerance or seeking fertility treatment. The trials detailed in the publication demonstrate significant improvements associated with GLP-1 RAs, including reductions in body weight, insulin resistance, and cardiovascular disease markers. Some of these studies also showed enhancements in reproductive health outcomes, such as improved menstrual regularity and higher pregnancy rates. The combination therapy of GLP-1 RAs with metformin seemed especially promising, showing superior efficacy compared to the agents used individually in managing symptoms like hyperandrogenism and metabolic dysfunctions. Furthermore, GLP-1 RAs were noted for their safety, with the most common adverse effects being manageable gastrointestinal symptoms. The review suggests that these agonists are a viable therapeutic option for PCOS, offering a multifaceted approach to addressing the syndrome's diverse manifestations. [5]

A 2023 comprehensive analysis utilized various clinical trials to explore the potential benefits of GLP-1RAs in addressing the complex metabolic challenges associated with PCOS. The therapeutic potential of GLP-1RAs was examined in overweight women with PCOS, focusing on weight reduction, improvement of hyperlipidemia, and enhancement of insulin sensitivity. The findings demonstrated notable weight loss and significant reduction in glycated hemoglobin levels among participants treated with GLP-1RAs, indicating a positive impact on glucose metabolism. GLP-1RAs exert their effects via a dual mechanism by promoting satiety and reducing appetite, while also enhancing insulin secretion in a glucose-dependent manner. Moreover, the anti-inflammatory effects of these agents contributed to the overall improvement in metabolic parameters. However, long-term safety concerns, particularly relating to pancreatic and thyroid effects, prompted the recommendation for careful patient screening and monitoring throughout the treatment duration. [6]

A 2019 meta-analysis evaluated the therapeutic efficacy of GLP-1 receptor agonists in comparison to metformin for treating PCOS. The meta-analysis included eight RCTs involving a total of 462 participants. The results demonstrated that compared to metformin, GLP-1 receptor agonists significantly improved insulin sensitivity (standardized mean difference [SMD] −0.40; 95% CI −0.74 to −0.06) and resulted in greater reductions in BMI (SMD −1.02; 95% CI −1.85 to −0.19) and abdominal girth (SMD −0.45; 95% CI −0.89 to −0.00). Further analysis indicated that while GLP-1 receptor agonists were more effective in certain metabolic outcomes, there was no significant difference between the two treatments concerning menstrual frequency, serum total testosterone levels, and the free androgen index. The assessment also highlighted a higher incidence of nausea and headaches with GLP-1 receptor agonists compared to metformin. Despite these findings, the overall quality of evidence was deemed moderate to low, suggesting that the conclusions should be interpreted with caution and highlighting the need for more high-quality research to confirm the benefits of GLP-1 receptor agonists in managing PCOS. [7]

A 2025 meta-analysis systematically assessed the efficacy and safety of GLP-1RAs compared to metformin and placebo in managing body weight, glucose homeostasis, and hormone levels in women with PCOS. The analysis included data from 13 randomized controlled trials with a total of 397 participants receiving GLP-1RAs, 330 receiving metformin, and 68 receiving placebo. The results found that GLP-1RAs significantly reduced BMI, body weight, waist circumference, waist-to-hip ratio, and abdominal girth, with a P-value of less than 0.0001 in all cases. Improvements in glucose homeostasis were evident as GLP-1RAs led to significant reductions in fasting insulin levels, glucose levels at 2 hours post-oral glucose tolerance test, and HOMA-IR. However, no significant changes were observed in fasting glucose levels when compared to metformin. While GLP-1RAs improved certain hormone levels when compared to placebo, these effects were not more pronounced than those achieved with metformin. In terms of safety, GLP-1RAs were associated with an increased incidence of nausea, vomiting, and dizziness, signaling the need for cautious consideration in clinical practice. Overall, the findings suggest GLP-1RAs as a promising alternative or adjunct to metformin, especially for those prioritizing weight loss and managing insulin resistance in PCOS. [8]

A 2025 meta-analysis compared the efficacy and safety of GLP1RAs combined with metformin versus metformin alone in managing PCOS. The analysis encompassed eight randomized controlled trials, incorporating a total of 337 participants. This meta-analysis systematically evaluated the impact of the combination therapy on various metabolic and hormonal outcomes, including body weight, BMI, waist circumference, fasting glucose, insulin sensitivity (HOMA-IR), androgen levels, and sex hormone-binding globulin (SHBG). The results from this meta-analysis indicated that the combination of GLP1RAs and metformin provides superior benefits compared to metformin alone, particularly in reducing body weight (MD -1.37 kg), BMI (MD -0.88 kg/m²), and waist circumference (MD -2.46 cm), with improvements in fasting glucose levels and insulin sensitivity as well. The hormonal outcomes demonstrated an increase in SHBG (MD 10.04), although changes in testosterone levels were not found to be statistically significant. Adverse events were similar between the groups, reaffirming the safety of the combination therapy. Collectively, this meta-analysis supports the potential of GLP1RAs combined with metformin to more effectively address the metabolic and hormonal challenges associated with PCOS compared to metformin alone. [9]

A 2024 systematic review and meta-analysis evaluated the efficacy and safety of GLP-1RAs in the treatment of PCOS among obese women. The analysis synthesized data from eight RCTs, encompassing a total of 519 participants, and comparing GLP-1RAs with other treatments such as metformin and dapagliflozin. Results demonstrated that GLP-1RAs significantly improved insulin sensitivity and contributed to reductions in BMI and waist circumference compared to control treatments. However, no significant differences were observed between GLP-1RAs and controls in terms of serum total testosterone, menstrual frequency, and free androgen index. The meta-analysis also reported a slight improvement in HDL cholesterol levels associated with GLP-1RA use. Although adverse events such as diarrhea were more common in the GLP-1RA group, incidences of nausea and vomiting did not significantly differ. The findings suggest that GLP-1RAs could be a promising therapeutic option for obese women with PCOS, particularly those with insulin resistance, though further high-quality, long-term studies are warranted. [10]

A 2025 review article analyzed the dual impact of GLP-1RAs on metabolic and reproductive health in women with PCOS. The review highlighted various studies demonstrating GLP-1RAs' efficacy in reducing fasting plasma glucose and hemoglobin A1c levels, improving glucose tolerance, and promoting significant weight loss, which in turn alleviates both metabolic and cardiovascular risks associated with PCOS. Significantly, the review also explored the reproductive benefits of GLP-1RAs, emphasizing their role in restoring ovulation and menstrual regularity. The article presented data indicating that GLP-1RAs potentially modulate the hypothalamic-pituitary-gonadal axis, leading to a reduction in serum testosterone levels and an increase in ovulation rates. Clinical trials cited within the paper supported these claims, showing improved menstrual cyclicity and enhanced fertility outcomes in women with PCOS treated with GLP-1RAs. The review called for further research to solidify the understanding of the long-term reproductive impacts of GLP-1RAs, indicating their promising role in a multifaceted treatment approach for managing both the metabolic and reproductive challenges of PCOS. [11]

Background References: [1] Teede HJ, Tay CT, Laven JJE, et al. Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2023;108(10):2447-2469. doi:10.1210/clinem/dgad463
[2] Goldberg A, Graca S, Liu J, et al. Anti-obesity pharmacological agents for polycystic ovary syndrome: A systematic review and meta-analysis to inform the 2023 international evidence-based guideline. Obes Rev. 2024;25(5):e13704. doi:10.1111/obr.13704
[3] Forslund M, Wändell P, Forsberg L, et al. GLP-1 receptor agonist treatment in women with polycystic ovary syndrome-a systematic review and meta-analysis. Eur J Endocrinol. 2026;194(3):25-39. doi:10.1093/ejendo/lvag033
[4] Austregésilo de Athayde De Hollanda Morais B, Martins Prizão V, de Moura de Souza M, et al. The efficacy and safety of GLP-1 agonists in PCOS women living with obesity in promoting weight loss and hormonal regulation: A meta-analysis of randomized controlled trials. J Diabetes Complications. 2024;38(10):108834. doi:10.1016/j.jdiacomp.2024.108834
[5] Siamashvili M, Davis SN. Update on the effects of GLP-1 receptor agonists for the treatment of polycystic ovary syndrome. Expert Rev Clin Pharmacol. 2021;14(9):1081-1089. doi:10.1080/17512433.2021.1933433
[6] Szczesnowicz A, Szeliga A, Niwczyk O, Bala G, Meczekalski B. Do GLP-1 Analogs Have a Place in the Treatment of PCOS? New Insights and Promising Therapies. J Clin Med. 2023;12(18):5915. Published 2023 Sep 12. doi:10.3390/jcm12185915
[7] Han Y, Li Y, He B. GLP-1 receptor agonists versus metformin in PCOS: a systematic review and meta-analysis. Reprod Biomed Online. 2019;39(2):332-342. doi:10.1016/j.rbmo.2019.04.017
[8] Lin S, Deng Y, Huang J, et al. Efficacy and safety of GLP-1 receptor agonists on weight management and metabolic parameters in PCOS women: a meta-analysis of randomized controlled trials. Sci Rep. 2025;15(1):16512. Published 2025 May 13. doi:10.1038/s41598-025-99622-4
[9] Zhao Y, Jiang L, Li N, Cao J, Pi J. Comparison of GLP-1 Receptor Agonists Combined with Metformin Versus Metformin Alone in the Management of PCOS: A Comprehensive Meta-Analysis. Reprod Sci. 2025;32(5):1661-1675. doi:10.1007/s43032-025-01788-9
[10] Tong X, Song X, Zhang Y, Zhao Q. Efficacy and safety of glucagon-like peptide-1 receptor agonists in the treatment of polycystic ovary syndrome-A systematic review and meta-analysis. Arch Physiol Biochem. 2024;130(6):1005-1011. doi:10.1080/13813455.2024.2380422
[11] Hoteit BH, Kotaich J, Ftouni H, et al. The dual impact of GLP-1 receptor agonists on metabolic and reproductive health in polycystic ovary syndrome: insights from human and animal trials. Ther Adv Endocrinol Metab. 2025;16:20420188251383064. Published 2025 Oct 7. doi:10.1177/20420188251383064
Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

What are the benefits of GLP-1 inhibitors in patients with polycystic ovarian syndrome?

Level of evidence

B - One high-quality study or multiple studies with limitations  Read more→



Please see Tables 1-2 for your response.


Liraglutide 3 mg on weight, body composition, and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study
Design

Randomized, double-blind, placebo-controlled trial

N= 82

Objective To study the efficacy and safety of the GLP-1 analog liraglutide 3 mg (LIRA 3 mg) vs. placebo (PL) for reduction of body weight (BW) and hyperandrogenism in women with obesity and polycystic ovary syndrome (PCOS)
Study Groups

LIRA 3 mg (n= 55)

Placebo (n= 27)

Inclusion Criteria Women diagnosed with PCOS (NIH criteria), aged 18–45 years, BMI >30 kg/m2, irregular periods, biochemical hyperandrogenism, agreement to use effective contraception
Exclusion Criteria Diabetes diagnosis, smoking within 6 months, pregnancy or lactation, clinically significant systemic disease, uncontrolled hypertension, acute pancreatitis, use of certain medications within specified timeframes
Methods

Participants received liraglutide (LIRA) 3 mg or placebo once daily for 32 weeks with lifestyle intervention. Body weight and composition were measured by DXA, and oral glucose tolerance tests were conducted. Hormonal and metabolic parameters were assessed.

Duration 32 weeks
Outcome Measures

Primary: Changes in body weight and free androgen index (FAI)

Secondary: Changes in absolute body weight, waist circumference, BMI, total testosterone, DHEAS, menstrual frequency, fasting blood glucose, insulin sensitivity indices, lipids, and blood pressure

Baseline Characteristics   LIRA 3 mg (n= 44) Placebo (n= 23)
Absolute body weight, kg 111 ± 2.8 119 ± 4.7
Body mass index, kg/m2 41.6 ± 1.1 43.9 ± 1.7
Waist circumference, cm 111 ± 2.2 116 ± 3.3
Waist-to-hip ratio 0.85 ± 0.01 0.84 ± 0.02
Total body % fat 47.6 ± 0.8 48.2 ± 0.8
Free androgen index 6.9 ± 0.6 5.6 ± 0.4
Fasting blood glucose, mg/dL 96 ± 1.7 95 ± 2.4
Results   LIRA 3 mg Placebo-LIRA 3 mg p-Value
Mean percent weight loss 5.7 ± 0.75 1.4 ± 1.09 0.002
Frequency of ≥5% weight loss 25 (57%) 5 (22%) 0.009
Frequency of ≥10% weight loss 13 (29.5%) 2 (8.7%) 0.046
FAI significantly reduced with LIRA 3 mg compared with the PL where the mean FAI slightly increased.
Adverse Events Gastrointestinal events were reported in 58.2% of the LIRA 3 mg subjects and 18.5% of placebo subjects. Nausea was the most frequent adverse event, occurring in 25.5% of the LIRA 3 mg group and 11% of the placebo group
Study Author Conclusions LIRA 3 mg once daily appears superior to placebo in reducing body weight and androgenicity and improving cardiometabolic parameters in women with PCOS and obesity.
Critique

The study was well-designed with a randomized, double-blind, placebo-controlled approach, and included a well-defined cohort. However, the study had a relatively short duration of 32 weeks and a high dropout rate, which may affect the generalizability of the results. The absence of gold-standard measures for insulin sensitivity and the use of surrogate indices are limitations. Additionally, the study did not assess long-term effects or sustainability of weight loss.

Table 1 References:
[12] Elkind-Hirsch KE, Chappell N, Shaler D, Storment J, Bellanger D. Liraglutide 3 mg on weight, body composition, and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study. Fertil Steril. 2022;118(2):371-381. doi:10.1016/j.fertnstert.2022.04.027
Semaglutide delays 4-hour gastric emptying in women with polycystic ovary syndrome and obesity
Design

Single-blind, placebo-controlled trial

N= 20

Objective To evaluate the effect of once-weekly subcutaneous semaglutide 1.0 mg on the late digestive period of gastric emptying (GE) after ingestion of a standardized solid test meal by using technetium scintigraphy
Study Groups

Semaglutide group (n= 10)

Placebo group (n= 9)

Inclusion Criteria White women, aged 35 (32.3-40.8) years with a BMI of 37 (30.7-39.8) kg/m2, diagnosed with PCOS and obesity, recruited from outpatients at the Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre, Ljubljana
Exclusion Criteria Any known serious chronic illness, including diabetes mellitus, angina pectoris, coronary heart disease, congestive heart failure, severe renal and hepatic impairment, inflammatory bowel disease, gastroparesis, cancer, chronic obstructive lung disease, psychiatric and neurological disease. Other clinical features, including GE disorders such as gastroesophageal reflux, hypothyroidism, gastric resection, or medication that may alter GE. Metformin use, failure to ingest the entire meal, medications causing significant weight change, previous bariatric surgery, history of idiopathic acute pancreatitis, family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma, current smoking, pregnancy, expecting pregnancy or breastfeeding, allergy to study medication ingredients
Methods

Participants were randomized to either semaglutide or placebo. Semaglutide was initiated at 0.25 mg once weekly for 2 weeks, escalated to 0.5 mg/week for 2 weeks, then increased to 1.0 mg once weekly for 8 weeks. Gastric emptying was assessed by scintigraphy after ingestion of a standardized solid meal, using sequential static imaging and dynamic acquisition. Anthropometric measurements and fasting blood samples were collected at baseline and Week 13.

Duration 12 weeks
Outcome Measures Gastric retention, expressed as the percentage of tracer retained at specific times up to 4 hours after meal ingestion and the time taken for half the radiolabelled meal to empty from the stomach (T1/2)
Baseline Characteristics   Placebo group (n= 9) Semaglutide group (n= 10)
Weight, kg 93 (83-105.5) 104.5 (89.8-111.8)
BMI, kg/m2 31.0 (29.3-39.5) 37.9 (33.2-41.4)
Neck circumference, cm 36 (34-39.5) 36.8 (36-38.6)
Waist circumference, cm 94 (86.5-112) 104 (98-113.5)
Systolic BP, mmHg 123 (119-129) 122 (116.8-129.3)
Diastolic BP, mmHg 80 (73.5-84.5) 80 (77.3-88.8)
Pulse, beats/min 78 (68.5-92) 72 (71.3-80.5)
Glucose 0 min OGTT, mmol/L 5.7 (5.4-6) 5.6 (5.2-5.9)
Glucose 120 min OGTT, mmol/L 6.5 (5.3-7.5) 6.3 (5.7-6.7)
Insulin 0 min OGTT, mU/L 10.3 (8.2-25) 12.3 (10.8-15)
Insulin 120 OGTT min, mU/L 112 (50.7-183.5) 75.8 (49.5-94.1)
HOMA-IR 2.4 (2.1-6.5) 3.2 (2.7-3.5)
Glucose, mmol/L 4.9 (4.7-5.2) 4.8 (4.5-5.1)
HbA1c, mmol/mol 33 (33-37) 36(32-39)
Cholesterol, mmol/L 5.3 (4.5-6.1) 4.9 (4.5-5.4)
HDL, mmol/L 1.3 (1.1-1.7) 1.2 (1.1-1.5)
LDL, mmol/L 3 (2.5-3.5) 3 (2.7-3.6)
TG, mmol/L 1.2 (0.8-2.5) 1.3 (1.1-1.7)
FSH, E/L 6.5 (4.8-7.7) 5.5 (4.8-6.5)
LH, E/L 7.3 (6.1-13.3) 5.5 (2.9-9.7)
DHEAS, μmol/L 6.49 (4.73-8.09) 5.91 (4.31-11.45)
SHBG, nmol/L 34 (17.7-53) 23.3 (14.4-29)
FAI 4 (1.5-5.5) 3.5 (2.8-9.3)
Total testosterone, nmol/L 0.78 (0.7-1.17) 1.01 (0.7-1.57)
Free testosterone, pmol/L 5.27 (4.04-7.01) 8.27 (5.25-12.58)
Androstenedione, nmol/L 6.28 (4.93-9.79) 7.35 (4.98-8.91)
Results Characteristic, % of estimated retention of gastric contents Placebo group, N = 9 Semaglutide group, N = 10 p-Value
Ts 1 h 79 (74.5-81) 87 (84.8-89.3) <0.001
Ts 2 h 43 (36.5-53) 72 (60-78) 0.001
Ts 3 h 18 (13-32.5) 50 (35.5-58.8) 0.008
Ts 4 h 0 (0-10.5) 37 (17-47.5) 0.002
T1/2, min 118 (108-132) 171 (154-187.5) <0.001
Adverse Events Nausea and dyspepsia were the most common adverse events experienced by four out of 10 participants in the semaglutide group and by one out of nine subjects in the placebo group. Adverse events were transient, mild to moderate in severity and subsided with time
Study Author Conclusions Semaglutide markedly delayed 4-hour GE in women with PCOS and obesity.
Critique The study's strength lies in its use of scintigraphy, a reference method for assessing gastric emptying, and its focus on a specific cohort of obese women with PCOS without diabetes or other confounding factors. However, the small sample size and potential variability in gastric emptying may limit the generalizability of the findings. Additionally, the semaglutide group appeared to be heavier than the placebo group, which could have influenced the results, although BMI was not significantly associated with gastric emptying outcomes in previous studies.

 

Table 2 References:
[13] Jensterle M, Ferjan S, Leai L, et al. Semaglutide delays 4-hour gastric emptying in women with polycystic ovary syndrome and obesity. Diabetes Obes Metab. 2023;25(4):975-984. doi:10.1111/dom.14944