Tirzepatide plus metformin in PCOS
Short-Term Combined Treatment With Tirzepatide and Metformin for Overweight/Obese Chinese Women With Polycystic Ovary Syndrome: A Prospective, Open-Label, Randomised Controlled Trial
Yang Z et al. · Diabetes, Obesity and Metabolism
Study record
- Population
60 Chinese women aged 18–40 with PCOS, BMI ≥24 and infertility for more than 12 months; 30 randomized per group, 28 completers per group.
Read source · Full-text reportMethods 2.1–2.2; Results 3.1- Formulation
Tirzepatide injections plus oral metformin, compared with oral metformin alone. Exact product preparation and injection-device details have not been verified.
Inspect extraction gap · Full-text reportMethods 2.2 — Study Design- Route
Subcutaneous tirzepatide and oral metformin.
Read source · Full-text reportMethods 2.2- Dose & frequency
Both groups received metformin starting at 500 mg daily and increasing by 500 mg every three days, as tolerated, to 1,000 mg twice daily. The combination group added tirzepatide 2.5 mg weekly for four weeks, then 5 mg weekly through week 16. This describes supervised research.
Read source · Full-text reportMethods 2.2- Study design
Single-centre open-label randomized trial. Sample size was based on weight change, not pregnancy outcomes. Follow-up comparisons used 28 completers per group; many secondary outcomes were tested.
Read source · Full-text reportMethods 2.2 and 2.7; Tables 2–3- Duration
16-week treatment comparison, then eight weeks of barrier contraception and 24 weeks of conception follow-up. Tirzepatide stopped after week 16; metformin continued in both groups. Pregnancy outcomes were assessed during weeks 25–48, not during tirzepatide treatment.
Read source · Full-text reportMethods 2.2 and 2.6- Reported findings
Week-16 weight change was −10.4 kg with combination therapy versus −1.7 kg with metformin. During weeks 25–48, natural pregnancies occurred in 11/28 versus 4/28; total pregnancies in 16/28 versus 7/28. These are clinical pregnancies, not demonstrated live-birth benefits. Other assisted pregnancies did not differ significantly.
Read source · Full-text reportResults 3.2 and 3.7; Tables 2–3- Adverse events
No serious adverse events or deaths were reported. Nausea occurred in 7/30 versus 5/30, diarrhea in 5/30 versus 4/30, and vomiting in 2/30 each. Two metformin participants withdrew for gastrointestinal intolerance; combination withdrawals involved cholecystitis and herpes zoster. Withdrawal association does not establish causation.
Read source · Full-text reportResults 3.9 — Adverse Events- Monitoring
Medication adherence, safety and adverse events were assessed every four weeks. During conception follow-up, hCG testing was performed at visits and positive tests were followed by ultrasound to confirm a gestational sac. Barrier contraception was used through week 24.
Read source · Full-text reportMethods 2.2 and 2.6
What it supports
Reports greater short-term weight reduction and later pregnancy counts after a tirzepatide-plus-metformin treatment period in a selected PCOS population.
What it does not establish
Small open-label single-centre trial with completer outcomes and numerous secondary comparisons. Pregnancy was assessed after tirzepatide stopped; this does not support use during pregnancy or establish a general preconception regimen. Menstrual regularity is not confirmed ovulation. Lean-mass change in Table 2 does not reconcile with the displayed baseline/follow-up means. The retrieved supplement does not resolve the lean-mass discrepancy; registry reconciliation remains pending. Registration is unresolved: the cited identifier appears in an indexed registry record for empagliflozin, not tirzepatide; the full registry page was unavailable for confirmation.
Funding
Chongqing medical scientific research project (2025MSXM106), Chongqing Municipal Health Commission (2022ZDXM004), and Natural Science Foundation Project of Chongqing CSTC (CSTB2022NSCQ-MSX1008).
Literature search cutoff: 2026-09-08 · Not independently clinically reviewed
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