Adults 65 and older sought for study of whether drug will stop muscle loss
UT Health San Antonio researchers seek participants for a clinical research study to evaluate whether a medication will increase muscle function and mass in older adults.
“As we age, the size and strength of our muscles decline. This is called sarcopenia,” said study lead investigator Nicolas Musi, M.D., director of the Sam and Ann Barshop Institute for Longevity and Aging Studies at UT Health San Antonio.
“Sarcopenia is a major cause of disability and decline in physical function in older adults,” Dr. Musi said. “Certain interventions, such as resistance exercise, help to slow down this muscle decline, but they do not halt it.”
As part of a multicenter study, UT Health San Antonio will evaluate the oral medication BIO-101, which is a substance derived from plants. Study participants must be 65 or older, suffering from age-related sarcopenia and at risk of mobility disability.
Participants will be randomly assigned to one of three groups: those taking 350 milligrams of BIO-101 per day, those taking 700 milligrams of BIO-101 daily, or those taking only a placebo (sugar pill). Only the study coordinating center, by way of preprinted numbers on treatment kits, will know which participants are receiving which dosage.
Participants will take the medication/placebo for six months. Researchers will measure changes in:
- walking speed, which is strongly linked to health parameters including longevity;
- muscle strength, using an instrument called a dynamometer; and
- muscle size, using a DEXA scan similar to technology used to measure bone density for osteoporosis.
“Sarcopenia starts around the fourth decade of life—40 more or less,” Dr. Musi said. “That’s when the loss of muscle begins, and it goes downhill from there.”
This clinical trial is a phase 2 study of the clinical benefits, safety and tolerability of BIO-101.
Biophytis, a pharmaceutical company based in Paris, France, is funding the study conducted at sites in Belgium, France, Italy and the United States. The goal is to enroll 334 participants, include 30 in San Antonio.
For information on eligibility, please call the Barshop Clinical Research Call Center at (210) 450-0020.
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