HealthRX.com · Printable question sheet
Dose-claim check for a MOTS-c number offered to someone in their fifties or early sixties
Write down the dose you were offered and who offered it, then run it through this page's five questions. A claim that fails them belongs in the unverified-protocol column, however many websites repeat it.
The claim
Where you saw or heard itclinic, seller, video, friend
The amount, frequency and length of course claimed
Who is making the claim, and do they sell the product?
Source they citetrial number, paper, or none
Run the claim through five questions
Fill the middle column from the source itself, not from the seller's summary of it.
| Question | What the cited source actually shows | Pass? |
|---|---|---|
| Source: is the number from a registered protocol, a reported trial or a regulator, or from a seller? | ||
| Population: were people your age enrolled in enough numbers for a reported subgroup result? | ||
| Product: is the formulation and concentration the same as the one offered to you? | ||
| Outcome: was the regimen tested for benefit and harm, with a comparator and follow-up? | ||
| Adjustment: was any age, kidney, liver or interaction adjustment defined in advance and tested? |
Trial exclusions that may already apply to you
From the registry record of the only registered MOTS-c trial. If any box is ticked, its results will not describe you.
- Taking metformin, a GLP-1 receptor agonist or an SGLT2 inhibitor, now or in the past three months
- Diabetes
- Heart attack, stroke or unstable angina in the past six months, or uncontrolled blood pressure
- Reduced kidney function, significant liver disease or raised liver enzymes
- Cancer currently being treated
- Pregnant, breastfeeding or planning pregnancy
What is established today
- FDA identified no clinical studies with pharmacokinetic data for MOTS-c.[1]
- FDA's presentation notes that dose-response relationships have not been assessed even in animals.[2]
- The only registered trial describes its regimen only as a fixed dose once daily for 12 weeks, with no amount given, and has posted no results.[3]
- ICH E7 sets the geriatric threshold at 65, so drug-development guidance does not treat people in their fifties and early sixties as geriatric.[4]
Questions for whoever offers the dose
- Which human study tested this amount, and where are its results?
- Why this number for my age rather than any other?
- What product exactly, and who verified its identity and concentration?
- What harms will you watch for, and what would make us stop?
- Is there an approved treatment with tested dosing for the same goal?
Sources for the facts on this sheet
- U.S. Food and Drug Administration. FDA Briefing Document: MOTS-c-Related Bulk Drug Substances (MOTS-c (free base) and MOTS-c acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026. Accessed 2026-10-18. https://www.fda.gov/media/193347/download
- U.S. Food and Drug Administration. July 23, 2026 Meeting of the Pharmacy Compounding Advisory Committee: FDA Presentations (MOTS-c (free base) and MOTS-c acetate). Accessed 2026-10-18. https://www.fda.gov/media/193773/download
- U.S. National Library of Medicine, ClinicalTrials.gov (API v2 record). NCT07505745: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of MOTS-c (a Mitochondrial-Derived Peptide) in Adults With Prediabetes and Overweight/Obesity. Accessed 2026-10-18. https://clinicaltrials.gov/api/v2/studies/NCT07505745
- International Council for Harmonisation. ICH E7: Studies in Support of Special Populations: Geriatrics (Step 4, 24 June 1993). Accessed 2026-10-18. https://database.ich.org/sites/default/files/E7_Guideline.pdf
This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.