Human studies show endogenous MOTS-c biology during exercise, and a genuine randomized Phase 2a trial of administered subcutaneous MOTS-c is recruiting in adults with prediabetes and overweight/obesity; no efficacy results are posted yet.
Regulatory status
Not FDA-approved; FDA highlights absence of human drug-product exposure data.
Main limitations
Human metabolic efficacy, therapeutic dose, chronic safety or performance benefit.
Safety
Human drug safety, immunogenicity and long-term exposure are unknown.
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Human studies show endogenous MOTS-c biology during exercise, and a genuine randomized Phase 2a trial of administered subcutaneous MOTS-c is recruiting in adults with prediabetes and overweight/obesity; no efficacy results are posted yet.
What the evidence actually supports
✓Treat human biomarker studies and exogenous peptide administration as two separate evidence questions.
✓Update wording from 'no human programme' to 'trial underway, outcomes unknown'.
✓Explicitly prevent endogenous biology from being presented as injected-drug efficacy.
What is not established / key limitations
×No verified controlled human therapeutic dosing/efficacy evidence identified.
×No human efficacy result is available yet.
×Endogenous exercise response does not demonstrate benefit from exogenous injections.
Selected study & evidence records
MOTS-c response to acute exercise in humans
2021 · Randomized exercise physiology study · n=30
Human physiology study measured endogenous MOTS-c; it was not a therapeutic administration trial.
Human drug safety, immunogenicity and long-term exposure are unknown.
There is no established human therapeutic safety profile for exogenous MOTS-c; immunogenicity, peptide impurities and product-quality risks remain relevant.
Technical details
Mechanism / biologyMitochondrial-derived peptide implicated in cellular stress responses, metabolism and AMPK-related signalling.
Route / formulation boundaryEndogenous exercise-induced MOTS-c measurements are not evidence that injected MOTS-c is effective or safe.
Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.
Dosing evidence statusDosing research conclusion recorded. No controlled exogenous human administration regimen identified; human studies largely measure endogenous MOTS-c rather than administering it as a drug.
Identifiers & alternate namesMOTS C · MOTSC
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.