Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 40 to 80

Weight loss, exercise, and metformin for knee osteoarthritis in overweight adults

Official title: Anti-Diabetic Drug, Exercise and Healthy Diet for Knee Osteoarthritis With Overweight/Obesity, a Randomized Controlled Trial

Run by The University of Hong Kong · NCT07065591 · Data updated 2026-11-12

This study tests whether adding metformin to diet and exercise can reduce knee pain and body weight in adults with overweight or obesity and knee osteoarthritis who are considering knee replacement.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages40 Years to 80 Years
SexAll
Enrollment100 (estimated)
SponsorThe University of Hong Kong
Academic / other
Locations1 site (Hong Kong, Sandy Bay)
StatusRecruiting
StartedAugust 30, 2026
Main results expectedApril 17, 2028
Study endsJuly 17, 2028
Registry record updatedAugust 18, 2026
Trial IDNCT07065591 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 40–80 with knee OA, BMI ≥23 kg/m2, knee pain for at least 6 months, and considering joint replacement.

Probably not a fit

Those with advanced knee OA or contraindications to metformin may are less likely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study investigates whether a combined lifestyle program of diet modification and structured exercise, with the addition of metformin, can improve knee OA symptoms and reduce weight in overweight or obese adults. Participants are adults 40–80 with knee OA, persistent knee pain, and BMI in the overweight/obese range, and they are candidates for knee replacement consideration. The trial compares metformin to placebo as an adjunct to lifestyle interventions. Primary outcomes focus on changes in pain and body weight, with secondary outcomes including functional measures and potential impact on future knee replacement needs. The study is conducted at a single Hong Kong site under the University of Hong Kong.

Why it matters

Potential benefit: If successful, participants may experience reduced knee pain and body weight, potentially slowing OA progression and delaying the need for knee replacement.

How similar studies have gone: Previous weight-management and lifestyle approaches have shown pain reduction in KOA, with metformin being explored for weight control and metabolic benefits in OA contexts; this combination is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Men and women age between 40 and 80 years old, with overweight or obesity (body mass index ≥23 kg/m2) according to Hong Kong Centre for Health Protection definition of overweight and obesity.
* Knee pain for 6+ months with Visual Analogue Scale (VAS) \> 40mm/100mm and
* Meet the American College of Rheumatology criteria for knee OA
* OA referred for consideration for joint replacement

Exclusion Criteria:

* Severe radiographic knee OA (Kellgren-Lawrence grade 4) or severe knee pain (VAS\>80mm/100 mm) that could not tolerate further conservative management;
* inflammatory arthritis like rheumatoid arthritis, crystal arthritis, etc.
* Preexisting diabetes on antidiabetic drug or drug allergy to metformin.
* Recent knee surgery of the same knee
* Significant bone loss.
* Concomitant neuromuscular diseases affecting lower limb function.
* renal or liver impairment precluding use of metformin.
* VitaminB12 deficiency

Where it's running

  • Maclehose Medical Rehabilitation
    Hong Kong, Sandy Bay, Hong Kong
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.