ClinicalTrials.gg
RecruitingNCT06924658Updated Sep 30, 2026

Metformin in Safety and Efficacy in Gouty Patients

A Phase 2 interventional study of placebo and Metformin in Gout, sponsored by Mostafa Bahaa. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Mostafa Bahaa · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Updated Sep 30, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

02

Conditions studied

  • Gout

Browse trials for

03

In context

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

This study's planned enrollment of 70 is below the median of 83 across 286 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Mostafa Bahaa is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout.

Exclusion criteria

Exclusion Criteria:

  • Systemic disorders such as cardiovascular, neurological, coronary artery disease.
  • Hypertension, hyperlipidemia, diabetes mellitus, active infections.
  • Other inflammatory or diseases.
  • Patients on biologics,
  • Cases with to metformin and those with impaired liver and kidney functions.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Control group

    this group will receive placebo in addition to the traditional lines of treatment of gout.

    Other: placebo

  • Active comparator
    Metformin group

    This group will receive metformin (1000mg/day) in addition to the traditional lines of treatment of gout.

    Drug: Metformin

Interventions

  • Otherplacebo

    Placebo will have the same look of metformin

  • Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

06

What researchers measure

Primary outcomes

  1. - Clinical assessment of disease activity

    \- Clinical assessment of disease activity by assessing patient and physician VAS visual analog scale (0-10 cm);

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Nov 2027, 31 months after the start.

Of 30 phase 2 interventional studies under Gout, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's planned 31 months is above that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Nov 2026 → Nov 2027 and completion Nov 2026 → Nov 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2025
First posted
Apr 11, 2025
StartActual
Apr 20, 2025
Primary completionEst.
Nov 20, 2027was Nov 2026
CompletionEst.
Nov 20, 2027was Nov 2026
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Nov 20, 2026→Nov 20, 2027
Sep 30, 2026
Study completion
Nov 20, 2026→Nov 20, 2027
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Primary completion Nov 20, 2026→Nov 20, 2027
    Study completion Nov 20, 2026→Nov 20, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06924658
Lead sponsor
Mostafa Bahaa
Responsible party
Mostafa Bahaa (Lecturer, Tanta University) — Sponsor-investigator
First posted
Apr 11, 2025
Start date
Apr 20, 2025
Primary completion
Nov 20, 2027 (estimated)
Completion
Nov 20, 2027 (estimated)
Last update
Sep 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Studies of the drug tested here: Metformin

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