A Phase 4 interventional study of Metformin Hydrochloride 500 MG and Semaglutide, 1.34 mg/mL in PCOS (Polycystic Ovary Syndrome) and Semaglutide, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to female participants aged 22 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-03-25.
Sponsored by Peking University First Hospital · Phase 4, Interventional, and Treatment
To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. All subjects will be treated for 12 weeks, and then stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks for pregnancy outcome. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.
To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. Metformin and semaglutide will be administered in a dose increasing mode, and then maintain until the end of 12 weeks, and metabolic related indexes will be evaluated. After 12 weeks of treatment, all subjects will stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks to evaluate the fertility related indicators. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.
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About 25 subjects will be allocated to this group to receive metformin only, as the active comparator of semaglutide groups. Metformin used in this trial is Glucophage ( 500mg per tablet）produced by Bristol-Myers Squibb.The initial dose of metformin will be 500mg twice daily, which will be increased to 1000mg twice daily after two weeks, and then maintained until the end of treatment in total 12 weeks.
Drug: Metformin Hydrochloride 500 MG · Behavioral: calorie-restricted diet · Behavioral: physical exercise
About 25 subjects will be allocated to this group to receive semaglutide only, as one of the experimental groups. Semaglutide used in this trial is WEGOVY (semaglutide) injection produced by Novo Nordisk. Administer WEGOVY once weekly, on the same day each week, at any time of day, with or without meals. Inject subcutaneously in the abdomen, thigh or upper arm. Initiate at 0.25 mg once weekly for 4 weeks. In 4 week intervals, increase the dose until a dose of 1.0 mg is reached, and then maintained 1.0 mg until the end of treatment in total 12 weeks..
Drug: Semaglutide, 1.34 mg/mL · Behavioral: calorie-restricted diet · Behavioral: physical exercise
About 25 subjects will be allocated to this group to receive both semaglutide and metformin, as another of the experimental groups. Metformin used in this trial is Glucophage ( 500mg per tablet）produced by Bristol-Myers Squibb.The initial dose of metformin will be 500mg twice daily, which will be increased to 1000mg twice daily after two weeks, and then maintained until the end of treatment in total 12 weeks. Semaglutide used in this trial is WEGOVY (semaglutide) injection produced by Novo Nordisk. Administer WEGOVY once weekly, on the same day each week, at any time of day, with or without meals. Inject subcutaneously in the abdomen, thigh or upper arm. Initiate at 0.25 mg once weekly for 4 weeks. In 4 week intervals, increase the dose until a dose of 1.0 mg is reached, and then maintained 1.0 mg until the end of treatment in total 12 weeks.
Drug: Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG · Behavioral: calorie-restricted diet · Behavioral: physical exercise
Metformin oral tablet (500mg per tablet) will be administered in a dose increasing mode: the initial dose will be 500mg twice daily, which will be increased to 1000mg twice daily after two weeks, and then maintained until the end of treatment in total 12 weeks.
Also known as: Glucophage
Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and increased to 1.0mg QW after another 4 weeks, and then maintained 1.0mg until the end of treatment in total 12 weeks.
Also known as: WEGOVY
Both Semaglutide injection and Metformin oral tablet will be administered as described above.
Also known as: WEGOVY and Glucophage
All subjects after randomization will be reviewed and evaluated by a nutritionist, and then will receive diet guidance. The clinical nutritionist will develop a written nutrition plan for each subject. The nutrition plan of this study adopted the method of calorie restriction diet (CRD) to develop a diet, which required 83.68 kJ/kg of energy per day, 1.2 g/kg of protein per day, 40%\~55% of carbohydrate energy supply ratio, and 20%\~30% of fat energy supply ratio, to ensure the intake of vegetables, fruits and other rich dietary fiber, and drinking more than 1.5 L per day. The nutritionist will explain the method of food exchange in detail to enrich the food types of patients. The diet diary will be distributed to each subject, and the subjects will be required to make a return visit once every four weeks, return the diet diary each time, and receive guidance according to their compliance.
All subjects after randomization will be reviewed and evaluated by a trainer, and then will receive guidance of physical exercise.The trainer will formulate an exercise plan for each subject. The exercise plan consists of 30 minutes of moderate and low intensity continuous aerobic exercise every day, with a frequency of 5-7 days/week. The form of exercise can be determined according to personal hobbies, such as fast walking, jogging, climbing, swimming, etc. The exercise diary will be distributed to each subject, and the subjects are required to make a return visit once every four weeks, return the exercise diary each time, and the trainer will provide guidance to the subjects according to their compliance.
Percentage change in bodyweight at 12 weeks for semaglutide versus metformin
Difference between body weight at 12 weeks and baseline divided by baseline body weight
Time frame: at the end of 12 weeks of treatment
Achievement of weight reduction of at least 5% at 12 weeks for semaglutide versus metformin
Proportion of patients with weight loss at least 5% at 12 weeks of treatment
Time frame: at the end of 12 weeks of treatment
HOMA-IR at 12 weeks of treatment
compare HOMA-IR at 12 weeks of treatment among three groups
Time frame: at the end of 12 weeks of treatment
testosterone level at 12 weeks of treatment
compare testosterone level at 12 weeks of treatment among three groups
Time frame: at the end of 12 weeks of treatment
androstenedione level at 12 weeks of treatment
compare androstenedione level at 12 weeks of treatment among three groups
Time frame: at the end of 12 weeks of treatment
FAI (Free Androgen Index) at 12 weeks of treatment
compare FAI at 12 weeks of treatment among three groups
Time frame: at the end of 12 weeks of treatment
Depression score by self-rating depression scale (SDS）at 12 weeks of treatment
Zung self-rating depression scale (SDS) contains 20 items. Each item is divided into four grades according to the frequency of symptoms, of which 10 are positive and 10 are negative. Positive scoring question rated as 1, 2, 3 and 4 in turn and reverse scoring questions rated as 4, 3, 2 and 1. Add all the scores to get the total rough score, and then multiply the rough score by 1.25 to get the integral part as the standard score. The lower the score, the better. According to the criteria of Chinese population, the cut-off value of SDS standard score is 53 points, of which 53-62 points is mild depression, 63-72 points is moderate depression, and more than 73 points is severe depression. SDS standard score ≥ 50 indicates depressive symptoms. Depression severity is evaluated by cumulative score of each item/80. Those below 0.5 are not depressed; 0.5-0.59 is mild depression; 0.6-0.69 is moderate to severe; more than 0.7 is severe depression.
Time frame: at the end of 12 weeks of treatment
Anxiety score by self-rating anxiety scale (SAS）at 12 weeks of treatment
Zung self-reating anxiety scale (SAS) adopts a four-grade score, which is mainly used to assess the frequency of symptoms. The standard is: "1" means no or little time; "2" means sometimes; "3" means most of the time; "4" means most or all of the time. Of the 20 items, 15 items are stated in negative words, and scored in the order of 1-4 above. The remaining five items are stated in positive words and scored in reverse order of 4 to 1. The main statistical indicator of SAS is the total score. Add the scores of 20 items to get a rough score. Multiply the rough score by 1.25 and take the integer part to get the standard score. According to the criteria of Chinese population, the cut-off value of SAS standard score is 50 points, of which 50-59 points is mild anxiety, 60-69 points is moderate anxiety, and more than 70 points is severe anxiety.
Time frame: at the end of 12 weeks of treatment
Diet score by TFEQ-18 (three factor eating questionaire) at 12 weeks of treatment
The Three-Factor Eating Questionnaire Revised 18-item includes three dimensions of questions: non-controlled eating (9 items), cognitive restricted eating (6 items), and emotional eating (3 items). Uncontrolled eating refers to a tendency to lose control of excessive eating when feeling hungry or stimulated by external factors. Cognitive restriction refers to consciously limiting food intake to control weight or promote weight loss. Emotional eating refers to the tendency to overeat under some negative emotional conditions. Questions 1 to 18 are scored with 1 to 4 points. The total score of the three dimensions is the total score of the scale. The higher the score of each dimension of the questionnaire, the higher the tendency of uncontrolled eating, cognitive restriction of eating and emotional eating.
Time frame: at the end of 12 weeks of treatment
Quality of life score at 12 weeks of treatment
The World Health Organization Quality of Life (WHOQOL) - BREF can generate scores in four fields. The scale contains two independent analysis items: Q1 asks the individual's total subjective feelings about their own quality of life, and Q2 asks the individual's total subjective feelings about their own health status. The domain score is positive (that is, the higher the score, the better the quality of life). The domain score is obtained by calculating the average score of the items to which it belongs and multiplying by 4.
Time frame: at the end of 12 weeks of treatment
Ovulation rate at 24 weeks of follow-up after the end of treatment
Number of patients with ovulation after natural and ovulation induction treatment/total number of patients
Time frame: at the end of 24 weeks of follow-up after the end of treatment
Clinical pregnancy rate at 24 weeks of follow-up after the end of treatment
Clinical pregnancy rate=clinical pregnancy cycles/transplantation cycles
Time frame: at the end of 24 weeks of follow-up after the end of treatment
Cumulative pregnancy rate at 24 weeks of follow-up after the end of treatment
Cumulative pregnancy rate=number of all pregnant patients/total number of patients
Time frame: at the end of 24 weeks of follow-up after the end of treatment
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Peking University First Hospital