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Anti-diabetic drug

Metformin for Fibromyalgia

Phase 2
Recruiting
Led By Akiko Okifuji, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-14 weeks

Summary

This trial will study if low-dose metformin can improve fibromyalgia symptoms by altering neuroinflammatory pathways. It'll compare those taking the medication to those taking a placebo.

Who is the study for?
This trial is for individuals who can follow English instructions, take oral medication, and adhere to a daily regimen. Participants must meet the criteria for Fibromyalgia Syndrome as per the American College of Rheumatology 2016. Those with diabetes, pregnancy or planning to become pregnant, serious organ diseases, autoimmune disorders, neuropathic pain, terminal illness-related pain or using weight control meds cannot join.
What is being tested?
The INFORM Trial is testing if low-dose metformin improves fibromyalgia symptoms by affecting neuroinflammatory pathways. It compares the effects of metformin against a placebo in improving symptoms and altering certain cellular markers related to inflammation and pain signaling.
What are the potential side effects?
While not specified here, common side effects of metformin include digestive issues like nausea and diarrhea; it may also cause vitamin B12 deficiency over time. Side effects are generally mild but vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS
Secondary study objectives
Examine adherence
Examine changes in ecological momentary assessment (EMA) symptoms
Examine changes in individual FMS symptoms - Anxiety
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 1: Metformin TreatmentActive Control1 Intervention
500 mg metformin ER tablets once daily in the morning with a glass of water for 8 weeks.
Group II: 2: PlaceboPlacebo Group1 Intervention
Matching metformin ER placebo tablets once daily in the morning with a glass of water for 8 weeks.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,714 Total Patients Enrolled
5 Trials studying Fibromyalgia
440 Patients Enrolled for Fibromyalgia
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,440 Total Patients Enrolled
26 Trials studying Fibromyalgia
13,452 Patients Enrolled for Fibromyalgia
Akiko Okifuji, PhDPrincipal InvestigatorUniversity of Utah
3 Previous Clinical Trials
360 Total Patients Enrolled
3 Trials studying Fibromyalgia
360 Patients Enrolled for Fibromyalgia

Media Library

Metformin (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT05900466 — Phase 2
~29 spots leftby Dec 2025
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