Phase II TJ0113 trial in sarcopenia begins recruitment, with 400-meter walking speed as the primary measure

Phase II TJ0113 trial in sarcopenia begins recruitment, with 400-meter walking speed as the primary measure

On August 5, ClinicalTrials.gov reported that the study had begun recruitment. The phase II trial plans to enroll 204 people over 60 years of age with sarcopenia. For 26 weeks, they will receive one of three doses of TJ0113 or placebo each day.

Sarcopenia is an age-related loss of muscle mass, strength, and mobility. This protocol defines it as low muscle mass accompanied by reduced grip strength or impaired physical function. The trial will enroll people who already have this combination of features.

TJ0113 is being studied as a compound that induces mitophagy, the process by which cells recycle damaged or excess mitochondria, which produce energy for the cell. In a study of mice with acute liver failure, the authors reported changes in cellular markers of mitophagy. The sarcopenia trial will test this cellular hypothesis through an aspect of daily physical function in people: sustained walking speed.

Participants will be randomly assigned to receive daily doses of 100, 200, or 400 mg of TJ0113, or placebo. The primary measure will be the change in 400-meter walking speed at week 26. Comparisons with baseline speed and placebo will show whether walking speed changed differently across the four groups.