NCT06185179

Metformin and Muscle Recovery

Recruiting now EARLY_PHASE1 Last updated 5 December 2025

What this trial tests

EARLY_PHASE1 trial testing Metformin in Muscle Atrophy or Weakness in 50 participants. Currently enrolling.

Timeline

1 September 2024

Primary endpoint
31 May 2029

31 May 2030

Quick facts

Lead sponsor	University of Utah
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	1 September 2024
Primary completion	31 May 2029
Estimated completion	31 May 2030
Sites	1 location across United States

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• Placebo

Conditions studied

• Muscle Atrophy or Weakness — all drugs for Muscle Atrophy or Weakness →

Sponsor

University of Utah

Who can join

60 and older, any sex, with Muscle Atrophy or Weakness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A hallmark of aging is an impaired ability to adequately recover following a stressor, such as muscle disuse, resulting in muscle fibrosis and weakness thereby increasing the risk for falls and loss of independence. Mechanistic-based therapeutic strategies to enhance muscle recovery in older adults do not exist. Metformin has been implicated to have positive effects on muscle size and function through non-glycemic mechanisms. Metformin has been shown to enhance macrophage function and lessen cellular senescence burden by targeting SASP in a variety of muscle interstitial cells. However, the role of metformin to improve muscle recovery in older adults following disuse atrophy through immunomodulating and senomorphic mechanisms have not been examined. Therefore, the purpose of this study is to conduct a randomized, double blind, placebo-controlled clinical trial in older adult participants to determine if short-term metformin delivery (vs placebo) during the recovery phase following disuse atrophy can improve muscle regrowth.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cellular senescence as a key contributor to secondary neurodegeneration in traumatic brain injury and stroke.
   Huang Z, Xu P, Hess DC, Zhang Q. · · 2024 · cited 10× · PMID 39668354 · DOI 10.1186/s40035-024-00457-2
2. Sarcopenia and Muscle Aging: Updated Insights into Molecular Mechanisms and Translational Therapeutics.
   Nguyen TT, Dao T, Nguyen HT, Park JH, et al · · 2026 · cited 1× · PMID 41674227 · DOI 10.3803/enm.2025.2656