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Semaglutide versus metformin in patients with schizophrenia and metabolic syndrome: a randomized, open-controlled study

Semaglutide versus metformin in patients with schizophrenia and metabolic syndrome: a randomized, open-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095449
Enrollment
Unknown
Registered
2025-01-07
Start date
2025-01-07
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Intervention group:Semaglutide subcutaneously once a week, injection method (weeks 1-4, 0.25mg/week
Weeks 5-8, 0.5mg/week
Weeks 9-12, 0.75mg/week
If the patient has gastrointestinal reactions but agrees to continue the trial, the dose can be adjusted to 0.5mg/week), semaglutide injection will be distributed by the pharmacy to the nurse in the w
Control group:Give daily oral metformin tablets (dose 500mg/day, taken in 2 divided doses, with meals, breakfast and dinner
Increase by 500 mg/day weekly, up to a maximum of 2550 mg/day, or adjust the dose to 1500 mg/day if gastrointestinal reactions cannot be tolerated but agree to continue the trial).

Sponsors

Shenzhen Kangning Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained prior to any study group activity 2. Age greater than or equal to 18 years at the time of signing the informed consent 3. Patients who meet the diagnostic criteria for schizophrenia in the International Classification of Diseases, 10th edition (ICD-10), body mass index (BMI) >=30kg/m2 (obesity), or >=27kg/m2 and =3.4mmol/L), obstructive sleep apnea, cardiovascular disease.

Exclusion criteria

Exclusion criteria: 1. Have a history of type I diabetes; 2. Subjects with T2D at screening: uncontrolled and potentially unstable diabetic fundus lesions, diabetic nephropathy; 3. Patients with renal impairment at screening, serum creatinine > 150 µmol/L or eGFR 180mmHg or diastolic blood pressure >100mmhg). 4. Have taken weight loss medications within the last 90 days. 5. There are any contraindications to the use of semaglutide injection and metformin; 6. Patients receiving corticosteroids or other hormonal therapy (except estrogen); 7. Be in the acute mental illness (CGI-S score = 6) and have suicidal behavior at the time of screening; 8. Patients who plan to be pregnant or breastfeeding; 9. Substance abuse patients.

Design outcomes

Primary

MeasureTime frame
ADR incidence;Body Mass Index;

Secondary

MeasureTime frame
Serum insulin;Hipline;Clinical overall impression - Severity subscale;Positive and Negative Syndrome Scale 6-item;17 items Hamilton Depression Scale;Hamilton anxiety scale;Schizophrenia Cognitive Function Kit Chinese scale;Morisky medication compliance questionnaire;Waistline;serum insulin;C-peptide level;Glycosylated hemoglobin;Fasting blood-glucose;Postprandial blood sugar;Blood pressure;Serum lipid parameter;Electrocardiogram;Liver function index;Content of body fat;Chinese version of Quality of Life scale for schizophrenia patients;

Countries

China

Contacts

Public ContactZheng Caiji

Shenzhen Kangning Hospital

caijizheng@qq.com+86 755 82924215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026