Effects of combined metformin and semaglutide therapy on body weight, metabolic parameters, and reproductive outcomes in overweight/obese women with polycystic ovary syndrome: a prospective, randomized, controlled, open-label clinical trial
- Design
- Randomized trial · 80 participants · Biomarker outcome
- Match to healthy normal-weight adults aged 55–75
- Different population[Auto] Participants had obesity/overweight (age/BMI not reported in abstract).
- Could weight loss explain it?
- Possibly[Auto] Participants had obesity and/or type 2 diabetes and the abstract does not separate direct drug effects from weight loss or glycaemic improvement.
- Study tier
- Study tier 3[Auto] Small or short randomized trial (auto-provisional).
- Assessment
- Version 1 · automatic, not yet reviewed by a person · Sep 13, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
[Auto, unreviewed; quoted from abstract conclusions] Compared to MET monotherapy, combination therapy with semaglutide and MET significantly reduced body weight, improved insulin resistance, decreased inflammatory markers, alleviated and menstrual irregularities and increased natural pregnancy rates in overweight/obese women with PCOS.
01Findings
What the study reported
- Drugs
- Semaglutide
- Dose
- 1000 mg
- Treatment duration
- 16 weeks
- Comparator
- a combination of semaglutide and MET
- Primary outcome
- Not extracted
- Effect
- Not extracted
- 95% confidence interval
- Not extracted
- Follow-up
- 16 weeks
- Adverse events
- Not extracted
- Limitations
- Auto-classified from abstract only; effect estimates, adverse events and limitations not extracted. Requires manual review.
Who was studied
- Obesity status
- obesity/overweight present (all or most)
- Sample size
- 80
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- 80
- Randomization
- yes
- Blinding
- open-label
- Comparator
- not stated
- Follow up duration
- 16 weeks
- Outcome type
- biomarker
- Replication
- not assessed (auto)
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- INDIRECT
- Statistical precision
- not extracted
- Risk of bias
- not assessed (auto)
- Funding conflicts
- unclear
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- not reported in abstract
- Industry funded
- Unclear
- Manufacturer
- None identified
- Sponsor role
- not reported in abstract
- Author conflicts
- Declarations. Ethics approval and consent to participate: The study was approved by the hospital’s ethics committee of the Second Affiliated Hospital of Chongqing Medical University (Approval No. 2024204) and registered on Chinese Clinical Trial Registry (ChiCTR2400090908) in October 15, 2024. All participants received written and oral information and signed informed consent before any examination. Consent for publication: Not applicable. Disclaimers: Any opinions or recommendations discussed are solely those of the author(s). Source(s)of support: Chongqing medical scientific research project (Joint project of Chongqing Health Commission and Science and Technology Bureau) (2025MSXM106), the First batch of key Disciplines on Public Health in Chongqing, the National Natural Science Foundation of China (Grants 81501199 to C.W.), the Natural Science Foundation Project of Chongqing CSTC (cstc2017jcyjAX0016 to C.W. and CSTB2022NSCQ-MSX1008 to C.W.). Competing interests: The authors declare no competing interests.
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[OBJECTIVE] This study aimed to assess the effects of metformin (MET) monotherapy versus a combination of semaglutide and MET on weight, metabolism, reproductive function, and inflammatory markers in women with polycystic ovary syndrome (PCOS). [METHODS] A total of 100 overweight or obese women with PCOS diagnosed according to the Rotterdam criteria were randomly assigned to two groups: MET (1000 mg twice daily [BID] for 16 weeks) and combination therapy (COM) (1000 mg MET BID plus 1- mg semaglutide once weekly [QW] for 16 weeks). Primary outcomes, assessed at Week 0 and Week 16, included changes in anthropometric measures related to obesity, while the secondary outcomes included alterations in reproductive hormone levels, glucose and lipid metabolism, and C-reactive protein (CRP) levels, Between Weeks 16 and 40, all participants received metformin monotherapy (1000 mg BID) to evaluate pregnancy outcomes. [RESULT] A total of 80 participants (80%) completed the study. After 16 weeks of intervention, the COM group exhibited significantly greater reductions in body weight, BMI, and waist-to-hip ratio (WHR) compared to the MET group (all P < 0.01). The COM group experienced an average weight loss of 6.09 ± 3.34 kg, while the MET group lost only 2.25 ± 4.27 kg. The COM group also demonstrated greater improvements in testosterone (TEST), Chinese visceral adiposity index (CVAI), and CRP levels compared to the MET group. Additionally, the COM group showed higher rates of menstrual cycle recovery than the MET group. From weeks 16 to 40, the COM group demonstrated a significantly higher natural pregnancy rate than the MET group (35% vs. 15%, P < 0.05). [CONCLUSION] Compared to MET monotherapy, combination therapy with semaglutide and MET significantly reduced body weight, improved insulin resistance, decreased inflammatory markers, alleviated and menstrual irregularities and increased natural pregnancy rates in overweight/obese women with PCOS. [CLINICAL TRIAL REGISTRATION] chictr.org.cn ID: ChiCTR2400090908 (Registration time: 2024-10-15).
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 13, 2026 | 40713699 first ingestion |