Could a diabetes drug boost psoriasis treatment in overweight patients?
NCT ID NCT07485764
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding metformin (a diabetes drug) to the standard psoriasis treatment secukinumab works better than secukinumab alone for overweight or obese Chinese patients with moderate-to-severe plaque psoriasis. About 186 participants will be randomly assigned to receive either the combination or secukinumab plus a placebo. The main goal is to see if more patients achieve clear or almost clear skin after 24 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 186 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects voluntarily participate in the study and sign the informed consent form. 2. Aged 18-75 years (inclusive) at the time of signing informed consent, male or female. 3. Diagnosed with chronic plaque psoriasis for \>=6 months prior to the first study drug administration. 4. Overweight/obesity: Body mass index (BMI) \>=25 kg/m². 5. Moderate-to-severe plaque psoriasis (defined as): Psoriasis Area and Severity Index (PASI) score \>=12 at screening and prior to first dose. Investigator's Global Assessment (IGA) score \>=3 at screening and prior to first dose. Stable disease within 2 months prior to randomization. 6. Deemed candidates for phototherapy or systemic therapy by the investigator, defined as subjects with moderate-to-severe chronic plaque psoriasis uncontrolled by: Topical therapy and/or phototherapy and/or prior systemic therapy. 7. Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study medication (Day 0). Both women of childbearing potential and male patients with reproductive capacity must agree to use highly effective contraceptive methods during the study and for 15 weeks following the last dose. 8. Lactating women agree to discontinue breastfeeding during the study and for 15 weeks following the last dose of study medication. 9. Subjects must be capable of effective communication with investigators and adhere to the clinical trial protocol to complete all study requirements. - Exclusion Criteria: * 1: BMI \<25 kg/m². 2: Presence of guttate, pustular, or erythrodermic psoriasis, or other diseases that may confound treatment outcomes (e.g., cutaneous lesions, systemic autoimmune diseases). 3: Drug-induced psoriasis (e.g., new-onset or exacerbated psoriasis caused by beta-blockers, calcium channel blockers, or lithium). 4: Use of prohibited medications: Systemic non-biologic agents (e.g., glucocorticoids, leflunomide, methotrexate, cyclosporine, retinoids, azathioprine, mycophenolate mofetil, traditional Chinese medicines for psoriasis) within 4 weeks prior to screening. Etanercept or its biosimilars within 4 weeks prior to screening; TNF-α inhibitors or their biosimilars within 12 weeks prior to screening. Other biologic agents for psoriasis (e.g., IL-12/23 or IL-23 inhibitors) within 5 half-lives of the drug prior to screening. 5: Prior use of secukinumab or other IL-17A/IL-17R-targeted biologic agents within 12 weeks prior to screening. 6: History of malignancy within the past 5 years (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma in situ). 7: Active inflammatory diseases other than psoriasis that may confound the evaluation of secukinumab efficacy. 8: Metabolic or inflammatory diseases (e.g., type 2 diabetes) that may confound the evaluation of metformin efficacy. 9: History of lymphoproliferative disorders (e.g., lymphoma, lymphadenopathy) or splenomegaly. 10: Opportunistic infections within 6 months prior to screening (e.g., herpes zoster, CMV, Mycoplasma, Pneumocystis jirovecii, histoplasmosis, candidiasis, aspergillosis, NTM). 11: Chronic or recurrent infectious diseases (e.g., chronic hepatitis, pyelonephritis) or severe/life-threatening infections within 6 months prior to screening; current signs/symptoms suggestive of infection (e.g., fever, cough, dysuria, abdominal pain, diarrhea, infected skin wounds). 12: High risk of infection (e.g., leg ulcers, indwelling urinary catheters, recurrent chest infections, bedridden/wheelchair-bound status). 13: Major surgery within 8 weeks prior to screening or planned during the study, deemed to pose unacceptable risk by the investigator. 14: Live virus/bacterial vaccines (e.g., BCG) within 6 weeks prior to screening or planned during the study/within 15 weeks after last dose. 15: Participation in another clinical trial within 4 weeks prior to screening or within 5 half-lives of the investigational product (whichever is longer). 16: Laboratory abnormalities: Hemoglobin \<8.5 g/dL WBC \<2,500/μL ANC \<1,500/μL Platelets \<100,000/μL ALT/AST \>2×ULN Creatinine \>176.8 μmol/L (2.0 mg/dL) 17: Active hepatitis B (positive HBsAg). 18: Positive HCV antibody. 19: HIV infection or positive HIV antibody. 20: Syphilis infection. 21: Active or latent tuberculosis at screening. 22: Hypersensitivity to trial drug excipients, murine/human proteins, or immunoglobulin products. 23: Inability to communicate/comply (e.g., psychiatric disorders, frequent travel, lack of motivation). 24: Other conditions deemed by the investigator to compromise study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
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