In short
Clinical trials are studying 20-HYDROXYECDYSONE in older adults with sarcopenia, a condition marked by loss of muscle strength and function. The main goal is to evaluate efficacy and safety, including whether it can help delay major mobility disability. The trial data focus on non-disabled elderly patients with severe sarcopenia.
Key points
- Clinical trial data show 20-HYDROXYECDYSONE being studied in older adults with sarcopenia, including people with severe disease. The trial is a Phase 3, interventional, randomized, double-blind, placebo-controlled study. It is authorised and plans to enroll 932 participants. The main goal is to evaluate efficacy and safety, with a focus on time to onset of major mobility disability. The study population is non-disabled elderly patients, which means people who are still functioning at baseline.
Trial overview
The available trial data describe one study of 20-HYDROXYECDYSONE in older adults with sarcopenia, which is a condition linked to loss of muscle strength and function.
The study is titled SARA-31 and is designed to evaluate the efficacy and safety of BIO-101 in elderly patients with severe sarcopenia.
The brief summary says the study compares BIO101 350 mg twice daily by mouth with placebo in non-disabled older patients with sarcopenia.
Who is being studied
The target population is elderly patients who have severe sarcopenia and are still non-disabled at the start of the study.
This means the trial is focused on older people who may still move and function on their own, but who have a muscle condition that may put them at risk for later mobility problems.
Study design and phase
This is an interventional study, which means researchers are giving a treatment and then measuring the results.
The trial is described as randomized, double-blind, and placebo-controlled.
Randomized means participants are assigned by chance to a study group, double-blind means neither the participant nor the study team knows who gets which treatment, and placebo-controlled means one group receives an inactive comparison treatment.
The study phase is Phase 3, which is a later stage of clinical research usually used to test whether a treatment works in a larger group and to collect more safety information.
What the trial measures
The main outcome is time to onset of Major Mobility Disability (MMD).
In simple terms, this means the study is checking how long it takes before a participant develops serious trouble with movement or walking.
The brief summary also states that the study is designed to evaluate the hazard of major mobility disability, which means the researchers are looking at the risk over time.
Treatment groups
The trial includes a placebo group and a 20-HYDROXYECDYSONE-related study treatment group listed in the source as BIO-101.
The intervention list names 20-hydroxyecdysone as an oral treatment and also lists placebo hard capsules for comparison.
The source data do not provide additional details about dosing beyond the listed oral use and the brief summary statement.
Trial status and size
The trial status is Authorised, which means it has been approved to proceed in the listed setting.
The planned enrollment is 932 participants, showing that this is a large study for the condition being investigated.
Based on the available data, this is the only listed clinical trial for 20-HYDROXYECDYSONE in the provided source.