parallel randomized trial

NCT06896981

Comparison Between the Effects of Low-Dose Semaglutide With Metformin vs. Metformin Alone Over Metabolic Profile in Obese Polycystic Ovary Syndrome: A Phase II Randomized Controlled Trial

Polycystic ovary syndrome NCT06896981S000210

Design

Randomized: 31
Start year: 2025
Treatment: 16 weeks, follow-up 16 weeks
Countries: Bangladesh (1 sites)
Sponsor: Bangabandhu Sheikh Mujib Medical University (not reported)
Eligibility: reproductive age Bangladeshi women with PCOS and obesity, BMI 27.5 or above

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Metformin Metformin 1000 mg daily	lifestyle: standard	16
A2	Semaglutide 0.5 mg subcutaneous once weekly Metformin plus semaglutide	metformin 1000 mg/day; lifestyle: standard	15

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Metformin A1	Semaglutide 0.5 mg subcutaneous once weekly A2	Whole trial ALL
female	n			31

Analyses this trial contributes to

Results

5 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Percent body weight change (short trials) (1 lines; O10B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A2 vs A1	md	-4.6 percent				not stated; other; R0056150:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 16	not stated; randomized; R0056166:Results
	A2	events				0 / 15	not stated; randomized; R0056166:Results

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 16	not stated; randomized; R0056166:Results
	A2	events				0 / 15	not stated; randomized; R0056166:Results