MOTS-c Human Trials: What the Registry and Studies Show
A MOTS-c study is listed in ClinicalTrials.gov, but the registry has no posted results. Published human observations of natural MOTS-c levels do not establish the safety or benefit of administering the peptide.
Correction (September 29, 2026): An earlier version said that University of Southern California researchers had launched a Phase 1 MOTS-c trial and gave a participant count, doses, schedule, outcomes, and projected approval dates. The cited trial identifier does not resolve in ClinicalTrials.gov. Those unsupported claims have been removed. The registered study described below is a different record, first posted in 2026.
What has been studied?
The 2015 discovery paper identified MOTS-c as a 16-amino-acid peptide encoded in the mitochondrial 12S rRNA region. Administered MOTS-c reduced diet-related obesity and insulin resistance in mice. These animal findings do not establish a clinical benefit in people.
A 2021 study reported changes in the body’s own MOTS-c in human muscle and blood after exercise. The same paper tested administered MOTS-c for physical performance and aging outcomes in mice. Measuring a peptide in people is different from giving it to them; that study did not test MOTS-c treatment in humans.
What does the trial registry show?
ClinicalTrials.gov record NCT07505745, first posted April 1, 2026, lists a Phase 2 study of MOTS-c and placebo in adults with prediabetes and overweight or obesity. The record names Hudson Biotech as sponsor, reports a “Recruiting” status, and gives an estimated enrollment of 120. Its listed primary outcomes are change in insulin sensitivity and treatment-emergent adverse events. No results are posted in the registry as of this update.
A registry entry reports information submitted by the study’s responsible party. Its status and planned enrollment do not independently confirm that participants received MOTS-c, or show whether it is safe or effective. This record does not support the earlier claim about a USC Phase 1 study.
What remains unknown?
The FDA’s compounding safety page says it has not identified human exposure data for drug products containing MOTS-c administered by any route. The agency also identifies potential immunogenicity and peptide-impurity concerns for compounded MOTS-c products. That statement concerns administered products; it does not erase studies measuring naturally occurring MOTS-c in people.
Evidence level: very low for clinical use. The published papers above support biological and animal findings, while the listed trial has no posted results. Human treatment benefits and safety remain unestablished.
This article is for education only and is not medical advice.
Sources & Citations
- 4regulatoryCertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
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Disclaimer: This article is for educational purposes only and does not constitute medical advice. The information presented is based on current research but should not be used for diagnosis, treatment, or prevention of any disease. Always consult a qualified healthcare provider before making health decisions.