Metformin for Fibromyalgia Symptoms (INFORM Trial)

This study, called the INFORM Trial, is looking into whether a low dose of metformin can help improve symptoms for people with fibromyalgia syndrome (FMS). Metformin is a drug commonly used for type 2 diabetes. Researchers believe it might work by affecting pathways in the body related to inflammation. You could be eligible to join if you are between 18 and 75 years old, meet the criteria for fibromyalgia, and can take oral medication. The study will compare metformin to a placebo (an inactive pill) over 8 weeks to see if metformin is safe and effective in reducing FMS symptoms. The main goal is to see how well metformin works after about 12-14 weeks.

Study design: This interventional study plans to enroll 72 participants. It compares metformin to a placebo, meaning some participants will receive the active drug and others an inactive pill.
What's involved: Participants will take either metformin or a placebo once daily for 8 weeks. You must be willing to follow this medication regimen.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoints for symptom improvement will be measured at 12-14 weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Metformin for Fibromyalgia Symptoms (INFORM Trial)

Recruiting

PHASE2Ages 18–75InterventionalTreatment

University of Utah

~72 participants

Updated 2026-03-30 on ClinicalTrials.gov

What's tested:MetforminPlacebo

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS

Measured over 12-14 weeks

Conditions

Fibromyalgia Syndrome

Where it's being run

1 sites across 1 states

Utah1

Study leadership

Akiko Okifuji, PhD · PRINCIPAL_INVESTIGATOR · University of Utah
Norman Taylor, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Utah

Who to contact

Reiko Mitsunaga, RN

[email protected]

801-585-7695

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

To be able to follow the protocol in English

Fibromyalgia Syndrome: Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia

Ability to take oral medication and be willing to adhere to the metformin regimen (once daily)

Exclusion

Co-occurring progressive disease (self-report, physician-diagnosed)

Diabetes

Pregnancy or planning to be pregnant in the next year (all premenopausal participants will be tested)

Having known cardiovascular, liver, kidney or pulmonary diseases (self-report, physician-diagnosed)

Having known serious psychopathology (Clinician diagnoses of psychosis, organic mental disorder, or dissociative disorder, self-reported active suicidal intent, self-reported history of inpatient admission to a psychiatric ward in the past year, evidence or self-report of self-injurious behaviors in the past year, reported current or recent history (2years) of non-IV substance abuse, any history of recreational IV drug use)

Having autoimmune disorder (e.g., rheumatoid arthritis) (self-report, physician-diagnosed)

Having neuropathic pain (self-report, physician-diagnosed)

Having pain associated with a terminal illness, acute pain, pain associated with specific organ damage (eg, stomach ulcer) (self-report, physician-diagnosed)

Concurrent use of weight controlling medications (eg, Xenical)

Requiring an interpreter to communicate

Abnormal levels of creatinine, vitamin B12, or hepatic function panel

eGFR of below 45mL/min/1.73m2

What this trial measures

Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS12-14 weeks
Safety will be measured by the Fibromyalgia Impact Questionnaire, Revised (FIQ-R score and will measure overall FMS severity. The numeric scale ranges from 0-10 with 0 being "low difficulty" (better outcome) and 10 being "high difficulty" (worse outcome).

Trialytics