Short-Term Combined Treatment With Tirzepatide and Metformin for Overweight/Obese Chinese Women With Polycystic Ovary Syndrome: A Prospective, Open-Label, Randomised Controlled Trial
- Design
- Randomized trial · Mixed 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] In overweight/obese women with PCOS, low-dose tirzepatide combined with MET was associated with greater reductions in body weight and visceral fat, along with improvements in metabolic and reproductive outcomes compared with MET monotherapy.
01Findings
What the study reported
- Drugs
- Tirzepatide
- Dose
- 1000 mg
- Comparator
- the MET group
- 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)
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- not extracted
- Randomization
- yes
- Blinding
- open-label
- Comparator
- not stated
- Follow up duration
- 16 weeks
- Outcome type
- mixed
- 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
- no
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- Chongqing medical scientific research project (Joint project of Chongqing Health Commission and Science and Technology Bureau); Chongqing Municipal Health Commission; Natural Science Foundation Project of Chongqing CSTC
- Industry funded
- No
- Manufacturer
- None identified
- Sponsor role
- no manufacturer funding identified
- Author conflicts
- Any opinions or recommendations discussed are solely those of the author(s). The authors declare no conflicts of interest.
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[AIMS] This study aimed to assess the effects of low-dose tirzepatide combined with metformin (COM) versus metformin (MET) monotherapy in overweight/obese women with polycystic ovary syndrome (PCOS). [MATERIALS AND METHODS] Sixty overweight/obese women with PCOS were randomised to the MET group (1000 mg twice daily [BID]) or the COM group (MET: 1000 mg BID, tirzepatide: 5 mg once weekly [QW]) for 16 weeks. The primary outcome was the change in body weight. Secondary outcomes included changes in anthropometric measures other than body weight, body composition, reproductive hormone levels, metabolic and endocrine parameters, inflammatory markers and menstrual cycle regularity. All outcomes were assessed at baseline and week 16. After week 16, participants were switched to MET monotherapy. Barrier contraception was required for 8 weeks and pregnancy outcomes were subsequently evaluated between weeks 25 and 48. [RESULTS] After 16 weeks of treatment, compared with the MET group, the COM group resulted in greater reductions in weight (-1.7 ± 2.5 kg vs. -10.4 ± 3.5 kg; p < 0.001), body mass index (BMI) (-0.68 ± 1.82 vs. -4.12 ± 1.37 kg/m2; p < 0.001), visceral adipose tissue (VAT) (-4.67 ± 9.59 vs. -34.13 ± 15.33 cm2; p < 0.001) and reproductive endocrine-metabolic parameters. Menstrual cycle recovery and total pregnancy rate were higher in the COM group than in the MET group (p = 0.013 and p = 0.014, respectively). [CONCLUSIONS] In overweight/obese women with PCOS, low-dose tirzepatide combined with MET was associated with greater reductions in body weight and visceral fat, along with improvements in metabolic and reproductive outcomes compared with MET monotherapy. [TRIAL REGISTRATION] ChiCTR2400090908; chictr.org.cn.
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 13, 2026 | 42236268 first ingestion |