Polycystic Ovary SyndromePhase 2/3NCT05646199
Semaglutide vs Metformin in Polycystic Ovary Syndrome (PCOS)
A Phase 2/3 study testing Metformin and Semaglutide Injectable Product in people with Polycystic Ovary Syndrome, run by University of Hull at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to compare the effect of Semaglutide and metformin on weight loss in obese women with Polycystic Ovarian Syndrome (PCOS) over a 28-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin and Semaglutide Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2025to 30 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willingness and ability to provide signed informed consent prior to any trial activity.
- Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria [12].
- Body mass index ≥30 kg/m2
- Negative pregnancy test during screening visit and agree to use barrier contraception during the study period.
- Participants from all ethnicities who are English speakers
Who cannot join
- Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease, and androgen-secreting tumours will be excluded by appropriate tests.
- Confirmed type 2 diabetes and type 1 diabetes.
- Pregnancy, breastfeeding or intends to become pregnant.
- Subjects who are on any of the following medications within 3 months of screening:
- Metformin or other insulin-sensitizing medications (e.g. pioglitazone)
- Hormonal contraceptives (e.g. birth control pills, hormone-releasing implants. Locally acting hormone - containing IUD such as Mirena coil is permitted).
Show all 25Show fewer
- Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.)
- Clomiphene citrate or oestrogen modulators such as letrozole
- GnRH modulators such as leuprolide
- Minoxidil
- Have been involved in another medicinal trial (CTIMP) within the past four weeks.
- Presence or history of neoplasm within 5 years prior to screening. Basal skin carcinoma is allowed.
- History of pancreatitis
- Any regular medications that would affect weight management (such as steroids)
- Any contraindications for treatment with semaglutide.
- Participants under 18 years
- Participants who cannot adequately understand verbal and / or written explanations given in English.
- Confirmed excessive and compulsive drinking of alcohol i.e., alcohol abuse as determined from GP medical notes by the Fast Alcohol Screening Test (FAST) or history of previous alcohol abuse.
- Moderate to severe renal impairment (creatinine clearance [CrCl] ≤ 60 ml/min or estimated glomerular filtration rate [eGFR] ≤ 60 ml/min/1.73 m2.
- Severe hepatic insufficiency / and or significant abnormal liver function defines as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and / or alanine aminotransferase (ALT) > 3ULN.
- History of a major surgical procedure involving the stomach or small intestine which could affect absorption as judged by the investigator.
- Have severe and enduring mental health problems.
- Personal or first-degree relative history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer (MTC).
- Clinical or radiological evidence of thyroid nodules.
- Any contraindication to the administration of metformin.
Trial locations and contacts
1 site in 1 country.
Chair in Academic Diabetes, Endocrinology and Metabolism contact
United Kingdom1 site
Hull University Teaching Hospitals NHS Trust
Hull, HU32RW
Thozhukat Sathyapalan, MD FRCP, 01482675312, thozhukat.sathyaplan@hyms.ac.uk
Harshal Deshmukh, MBBS PhD, +441482 675312, harshaldeshmukh@nhs.net
About this study
Official title: The Effect of Semaglutide Compared to Metformin in Obese Women With Polycystic Ovary Syndrome (PCOS): a Randomised Controlled Study (Semaglutide-PCOS Trial).
The goal of this clinical trial is to compare the effect of Semaglutide and metformin on weight loss in obese women with Polycystic Ovarian Syndrome (PCOS) over a 28-week treatment period.
The main question it aims to answer is:
Read more
- Which of the 2 drugs, metformin or Semaglutide causes more weight loss when used over a 28 week treatment period in obese women with PCOS?
Participants will be divided into 2 groups by chance. In the first group, participants will be asked to take metformin orally. In the second group, participants will take Semaglutide by injection under the skin weekly.
The maximum duration of participation for the patients in the trial is 32 weeks.
Researchers will compare the weight reduction, quality of life and individuals' wellbeing between the two groups.
Read the detailed description
Background:
Polycystic ovary syndrome (PCOS) is one of the most common metabolic disorders that affects 6-20% of reproductive-aged women and has an increased risk for type 2 diabetes mellitus (T2DM) and cardiovascular disease. Obesity affects more than 50% of women with PCOS and has been demonstrated to play a vital role in the establishment of symptoms in these patients. Bariatric surgery has been shown to improve metabolic parameters but reports of dietary intervention studies have been variable. PCOS is associated with an increased risk of depressive symptoms and a low quality of life (QOL) with weight being a major contributor. Even modest weight loss of 5% of initial body weight has been shown to improve menstrual disturbance, testosterone levels, hyperlipidaemia, and insulin resistance in women with PCOS. Metformin, most commonly used medication for PCOS works by improving insulin sensitivity in peripheral tissues, inhibit hepatic glucose production and increase glucose disposal by the peripheral tissues.
It has been used for decades in treatment of PCOS with improvement in menstrual irregularities and possible reduction of androgen levels. However, the effect of metformin on body weight (a major contributor of pathophysiology and symptoms in PCOS) remained highly variable between these patients. The first observational study of metformin in PCOS reported weight loss during metformin therapy. In a randomised controlled trial (RCT) designed to investigate the effect of metformin in body weight reported a significant decrease in BMI in obese women independent of their lifestyle. The recent meta-analysis assessed the effectiveness of metformin in PCOS reported a significant effect on body mass index (BMI) in women with PCOS. It is clear, however, that metformin does not increase body weight and might help to limit weight gain. Along with wide variation in response metformin is not tolerated by 10-20% of women with PCOS mainly due to its gastrointestinal side effects. Therefore, it is imperative that investigators look beyond metformin in obese women with PCOS, as this has shown to improve metabolic and hormonal parameters.
In a pilot study, another glucagon like peptide - 1 receptor agonist (GLP-1RA), liraglutide 1.8mg daily for 6 months reduced weight in obese women with PCOS and age and body mass index matched control women. They also demonstrated that liraglutide 1.8mg daily for 6 months in young obese women with PCOS showed significant improvement in physical health, social health, psychological and hence quality of life in this group.
Semaglutide a new GLP-1RA approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and is associated with significant weight loss. In patients with type 2 diabetes, there was ≥5% weight loss in 63% of patients treated with Semaglutide. On the other hand, liraglutide has shown around 5-7 kg of weight reduction from the baseline in patient with T2DM. However, it has been previously reported in the SUSTAIN trials, Semaglutide-treated subjects have achieved a significant weight loss of >10% compared to placebo. The effect of Semaglutide on weight loss and resultant improvement in the metabolic parameters and QOL in women with PCOS is unknown. In a recent double-blind randomized trial, compared Semaglutide to liraglutide in obese patients with no diabetes has shown a significant weight loss compared to placebo. Liraglutide is administered as a daily subcutaneous injection whereas Semaglutide is administered as a weekly subcutaneous injection. Therefore, investigators are conducting this trial to assess the feasibility and trying to replicate the greater weight loss with Semaglutide that has already been shown in other trial, in obese women with PCOS.
Overall hypothesis:
Treatment with Semaglutide will result in significant weight loss compared to metformin and that will be associated with significant improvements in hormonal and metabolic parameters, quality of life and cardiovascular risk factors as secondary endpoints in obese women with PCOS.
This is a randomized controlled trial
The trial consists of 7 visits and 3 telephone calls. Patients will be randomized on a 1:1 ratio to receive either:
Semaglutide 0.25mg subcutaneous weekly for 4 weeks followed by semaglutide 0.5 mg weekly for 4 weeks, then escalating to semaglutide 1 mg/ week for 4 weeks, followed by semaglutide 1.7 mg/week for 4 weeks before titrated up to maximum dose of 2.4 mg a week for 12 weeks if tolerated.
Or Metformin 500 mg/ day for 1 week followed by 500mg/twice a day for 1 week titrated up to 500 mg / day with breakfast and 1000 mg/ day with evening meals for 26 weeks if tolerated.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Semaglutide Injectable Product
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Participants will receive metformin
Semaglutide Injectable ProductDrug
Participants in this group will receive injectable Semaglutide
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Participants in this group will be given metformin Receives: Drug: Metformin |
| Semaglutide | Active comparator | Participants in this group with receive Semaglutide Receives: Drug: Semaglutide Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss (kg)
Changes in weight from baseline
Measured: 28 weeks
Secondary outcomes (5)
Fat mass
Changes in body fat percentage (%) measured using TANITA
Measured: 28 weeks
Free androgen index (FAI)
Changes in Free androgen index (%) calculated from testosterone and sex hormone binding globulin; FAI= (Total Testosterone/Sex Hormone binding globulin)X100%
Measured: 28 weeks
Blood pressure
Changes in blood pressure (mmHg)
Measured: 28 weeks
Pulse rate
Changes in pulse rate (beats per minute)
Measured: 28 weeks
Glucose tolerance
Changes in glucose reading (mmol/l) at 2 hours following 75g of oral glucose
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thozhukat Sathyapalan, MD, FRCP, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646199
- Sponsor's protocol ID
- R2603
- Status last verified
- May 2024
- First submitted
- 17 Nov 2022
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teede HJ, Joham AE, Paul E, Moran LJ, Loxton D, Jolley D, Lombard C. Longitudinal weight gain in women identified with polycystic ovary syndrome: results of an observational study in young women. Obesity (Silver Spring). 2013 Aug;21(8):1526-32. doi: 10.1002/oby.20213. Epub 2013 Jul 2.
PubMed 23818329Ovalle F, Azziz R. Insulin resistance, polycystic ovary syndrome, and type 2 diabetes mellitus. Fertil Steril. 2002 Jun;77(6):1095-105. doi: 10.1016/s0015-0282(02)03111-4.
PubMed 12057712Shaw LJ, Bairey Merz CN, Azziz R, Stanczyk FZ, Sopko G, Braunstein GD, Kelsey SF, Kip KE, Cooper-Dehoff RM, Johnson BD, Vaccarino V, Reis SE, Bittner V, Hodgson TK, Rogers W, Pepine CJ. Postmenopausal women with a history of irregular menses and elevated androgen measurements at high risk for worsening cardiovascular event-free survival: results from the National Institutes of Health--National Heart, Lung, and Blood Institute sponsored Women's Ischemia Syndrome Evaluation. J Clin Endocrinol Metab. 2008 Apr;93(4):1276-84. doi: 10.1210/jc.2007-0425. Epub 2008 Jan 8.
PubMed 18182456Yildiz BO, Knochenhauer ES, Azziz R. Impact of obesity on the risk for polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Jan;93(1):162-8. doi: 10.1210/jc.2007-1834. Epub 2007 Oct 9.
PubMed 17925334Skubleny D, Switzer NJ, Gill RS, Dykstra M, Shi X, Sagle MA, de Gara C, Birch DW, Karmali S. The Impact of Bariatric Surgery on Polycystic Ovary Syndrome: a Systematic Review and Meta-analysis. Obes Surg. 2016 Jan;26(1):169-76. doi: 10.1007/s11695-015-1902-5.
PubMed 26431698Moran LJ, Ko H, Misso M, Marsh K, Noakes M, Talbot M, Frearson M, Thondan M, Stepto N, Teede HJ. Dietary composition in the treatment of polycystic ovary syndrome: a systematic review to inform evidence-based guidelines. Hum Reprod Update. 2013 Sep-Oct;19(5):432. doi: 10.1093/humupd/dmt015. Epub 2013 May 31. No abstract available.
PubMed 23727939Thomson RL, Brinkworth GD, Noakes M, Clifton PM, Norman RJ, Buckley JD. The effect of diet and exercise on markers of endothelial function in overweight and obese women with polycystic ovary syndrome. Hum Reprod. 2012 Jul;27(7):2169-76. doi: 10.1093/humrep/des138. Epub 2012 May 2.
PubMed 22552687Barnard L, Ferriday D, Guenther N, Strauss B, Balen AH, Dye L. Quality of life and psychological well being in polycystic ovary syndrome. Hum Reprod. 2007 Aug;22(8):2279-86. doi: 10.1093/humrep/dem108. Epub 2007 May 30.
PubMed 17537782Thomson RL, Buckley JD, Noakes M, Clifton PM, Norman RJ, Brinkworth GD. The effect of a hypocaloric diet with and without exercise training on body composition, cardiometabolic risk profile, and reproductive function in overweight and obese women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Sep;93(9):3373-80. doi: 10.1210/jc.2008-0751. Epub 2008 Jun 26.
PubMed 18583464Sathyapalan T, Cho LW, Kilpatrick ES, Coady AM, Atkin SL. A comparison between rimonabant and metformin in reducing biochemical hyperandrogenaemia and insulin resistance in patients with polycystic ovary syndrome (PCOS): a randomized open-label parallel study. Clin Endocrinol (Oxf). 2008 Dec;69(6):931-5. doi: 10.1111/j.1365-2265.2008.03260.x. Epub 2008 Apr 10.
PubMed 18410553
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Semaglutide Compared to Metformin in Obese Women With Polycystic Ovary Syndrome (PCOS): a Randomised Controlled Study (Semaglutide-PCOS Trial).
- ClinicalTrials.gov ID
- NCT05646199
- Acronym / sponsor ID
- R2603
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effect of Semaglutide and metformin on weight loss in obese women with Polycystic Ovarian Syndrome (PCOS) over a 28-week treatment period.
The main question it aims to answer is:
- Which of the 2 drugs, metformin or Semaglutide causes more weight loss when used over a 28 week treatment period in obese women with PCOS?
Participants will be divided into 2 groups by chance. In the first group, participants will be asked to take metformin orally. In the second group, participants will take Semaglutide by injection under the skin weekly.
The maximum duration of participation for the patients in the trial is 32 weeks.
Researchers will compare the weight reduction, quality of life and individuals' wellbeing between the two groups.
Detailed description
Background:
Polycystic ovary syndrome (PCOS) is one of the most common metabolic disorders that affects 6-20% of reproductive-aged women and has an increased risk for type 2 diabetes mellitus (T2DM) and cardiovascular disease. Obesity affects more than 50% of women with PCOS and has been demonstrated to play a vital role in the establishment of symptoms in these patients. Bariatric surgery has been shown to improve metabolic parameters but reports of dietary intervention studies have been variable. PCOS is associated with an increased risk of depressive symptoms and a low quality of life (QOL) with weight being a major contributor. Even modest weight loss of 5% of initial body weight has been shown to improve menstrual disturbance, testosterone levels, hyperlipidaemia, and insulin resistance in women with PCOS. Metformin, most commonly used medication for PCOS works by improving insulin sensitivity in peripheral tissues, inhibit hepatic glucose production and increase glucose disposal by the peripheral tissues.
It has been used for decades in treatment of PCOS with improvement in menstrual irregularities and possible reduction of androgen levels. However, the effect of metformin on body weight (a major contributor of pathophysiology and symptoms in PCOS) remained highly variable between these patients. The first observational study of metformin in PCOS reported weight loss during metformin therapy. In a randomised controlled trial (RCT) designed to investigate the effect of metformin in body weight reported a significant decrease in BMI in obese women independent of their lifestyle. The recent meta-analysis assessed the effectiveness of metformin in PCOS reported a significant effect on body mass index (BMI) in women with PCOS. It is clear, however, that metformin does not increase body weight and might help to limit weight gain. Along with wide variation in response metformin is not tolerated by 10-20% of women with PCOS mainly due to its gastrointestinal side effects. Therefore, it is imperative that investigators look beyond metformin in obese women with PCOS, as this has shown to improve metabolic and hormonal parameters.
In a pilot study, another glucagon like peptide - 1 receptor agonist (GLP-1RA), liraglutide 1.8mg daily for 6 months reduced weight in obese women with PCOS and age and body mass index matched control women. They also demonstrated that liraglutide 1.8mg daily for 6 months in young obese women with PCOS showed significant improvement in physical health, social health, psychological and hence quality of life in this group.
Semaglutide a new GLP-1RA approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and is associated with significant weight loss. In patients with type 2 diabetes, there was ≥5% weight loss in 63% of patients treated with Semaglutide. On the other hand, liraglutide has shown around 5-7 kg of weight reduction from the baseline in patient with T2DM. However, it has been previously reported in the SUSTAIN trials, Semaglutide-treated subjects have achieved a significant weight loss of >10% compared to placebo. The effect of Semaglutide on weight loss and resultant improvement in the metabolic parameters and QOL in women with PCOS is unknown. In a recent double-blind randomized trial, compared Semaglutide to liraglutide in obese patients with no diabetes has shown a significant weight loss compared to placebo. Liraglutide is administered as a daily subcutaneous injection whereas Semaglutide is administered as a weekly subcutaneous injection. Therefore, investigators are conducting this trial to assess the feasibility and trying to replicate the greater weight loss with Semaglutide that has already been shown in other trial, in obese women with PCOS.
Overall hypothesis:
Treatment with Semaglutide will result in significant weight loss compared to metformin and that will be associated with significant improvements in hormonal and metabolic parameters, quality of life and cardiovascular risk factors as secondary endpoints in obese women with PCOS.
This is a randomized controlled trial
The trial consists of 7 visits and 3 telephone calls. Patients will be randomized on a 1:1 ratio to receive either:
Semaglutide 0.25mg subcutaneous weekly for 4 weeks followed by semaglutide 0.5 mg weekly for 4 weeks, then escalating to semaglutide 1 mg/ week for 4 weeks, followed by semaglutide 1.7 mg/week for 4 weeks before titrated up to maximum dose of 2.4 mg a week for 12 weeks if tolerated.
Or Metformin 500 mg/ day for 1 week followed by 500mg/twice a day for 1 week titrated up to 500 mg / day with breakfast and 1000 mg/ day with evening meals for 26 weeks if tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminParticipants in this group will be given metformin |
| Semaglutide | Active comparator | Drug: Semaglutide Injectable ProductParticipants in this group with receive Semaglutide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willingness and ability to provide signed informed consent prior to any trial activity.
- Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria [12].
- Body mass index ≥30 kg/m2
- Negative pregnancy test during screening visit and agree to use barrier contraception during the study period.
- Participants from all ethnicities who are English speakers
Key exclusion criteria (25 listed)
- Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease, and androgen-secreting tumours will be excluded by appropriate tests.
- Confirmed type 2 diabetes and type 1 diabetes.
- Pregnancy, breastfeeding or intends to become pregnant.
- Subjects who are on any of the following medications within 3 months of screening:
- Have been involved in another medicinal trial (CTIMP) within the past four weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminParticipants will receive metformin | Drug | Metformin |
| Semaglutide Injectable ProductParticipants in this group will receive injectable Semaglutide | Drug | Semaglutide |
Primary outcome
Weight loss (kg)
Time frame: 28 weeks
Changes in weight from baseline
5 secondary outcomes
Fat mass
Time frame: 28 weeks
Free androgen index (FAI)
Time frame: 28 weeks
Blood pressure
Time frame: 28 weeks
Pulse rate
Time frame: 28 weeks
Glucose tolerance
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 23818329Teede HJ, Joham AE, Paul E, Moran LJ, Loxton D, Jolley D, Lombard C. Longitudinal weight gain in women identified with polycystic ovary syndrome: results of an observational study in young women. Obesity (Silver Spring). 2013 Aug;21(8):1526-32. doi: 10.1002/oby.20213. Epub 2013 Jul 2.
- Background: PubMed 12057712Ovalle F, Azziz R. Insulin resistance, polycystic ovary syndrome, and type 2 diabetes mellitus. Fertil Steril. 2002 Jun;77(6):1095-105. doi: 10.1016/s0015-0282(02)03111-4.
- Background: PubMed 18182456Shaw LJ, Bairey Merz CN, Azziz R, Stanczyk FZ, Sopko G, Braunstein GD, Kelsey SF, Kip KE, Cooper-Dehoff RM, Johnson BD, Vaccarino V, Reis SE, Bittner V, Hodgson TK, Rogers W, Pepine CJ. Postmenopausal women with a history of irregular menses and elevated androgen measurements at high risk for worsening cardiovascular event-free survival: results from the National Institutes of Health--National Heart, Lung, and Blood Institute sponsored Women's Ischemia Syndrome Evaluation. J Clin Endocrinol Metab. 2008 Apr;93(4):1276-84. doi: 10.1210/jc.2007-0425. Epub 2008 Jan 8.
- Background: PubMed 17925334Yildiz BO, Knochenhauer ES, Azziz R. Impact of obesity on the risk for polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Jan;93(1):162-8. doi: 10.1210/jc.2007-1834. Epub 2007 Oct 9.
- Background: PubMed 26431698Skubleny D, Switzer NJ, Gill RS, Dykstra M, Shi X, Sagle MA, de Gara C, Birch DW, Karmali S. The Impact of Bariatric Surgery on Polycystic Ovary Syndrome: a Systematic Review and Meta-analysis. Obes Surg. 2016 Jan;26(1):169-76. doi: 10.1007/s11695-015-1902-5.
- Background: PubMed 23727939Moran LJ, Ko H, Misso M, Marsh K, Noakes M, Talbot M, Frearson M, Thondan M, Stepto N, Teede HJ. Dietary composition in the treatment of polycystic ovary syndrome: a systematic review to inform evidence-based guidelines. Hum Reprod Update. 2013 Sep-Oct;19(5):432. doi: 10.1093/humupd/dmt015. Epub 2013 May 31. No abstract available.
- Background: PubMed 22552687Thomson RL, Brinkworth GD, Noakes M, Clifton PM, Norman RJ, Buckley JD. The effect of diet and exercise on markers of endothelial function in overweight and obese women with polycystic ovary syndrome. Hum Reprod. 2012 Jul;27(7):2169-76. doi: 10.1093/humrep/des138. Epub 2012 May 2.
- Background: PubMed 17537782Barnard L, Ferriday D, Guenther N, Strauss B, Balen AH, Dye L. Quality of life and psychological well being in polycystic ovary syndrome. Hum Reprod. 2007 Aug;22(8):2279-86. doi: 10.1093/humrep/dem108. Epub 2007 May 30.
- Background: PubMed 18583464Thomson RL, Buckley JD, Noakes M, Clifton PM, Norman RJ, Brinkworth GD. The effect of a hypocaloric diet with and without exercise training on body composition, cardiometabolic risk profile, and reproductive function in overweight and obese women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Sep;93(9):3373-80. doi: 10.1210/jc.2008-0751. Epub 2008 Jun 26.
- Background: PubMed 18410553Sathyapalan T, Cho LW, Kilpatrick ES, Coady AM, Atkin SL. A comparison between rimonabant and metformin in reducing biochemical hyperandrogenaemia and insulin resistance in patients with polycystic ovary syndrome (PCOS): a randomized open-label parallel study. Clin Endocrinol (Oxf). 2008 Dec;69(6):931-5. doi: 10.1111/j.1365-2265.2008.03260.x. Epub 2008 Apr 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chair in Academic Diabetes, Endocrinology and Metabolism contact
Thozhukat Sathyapalan, MD, FRCP principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin and Semaglutide Injectable Product in people with Polycystic Ovary Syndrome, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chair in Academic Diabetes, Endocrinology and Metabolism (+441482675387, thozhukat.sathyapalan@hyms.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (kg) (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646199, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.