MOTS-MET Trial Record: What NCT07505745 Shows—and What It Does Not
The concise answer
No MOTS-MET trial results are posted yet for NCT07505745. With that important qualification, ClinicalTrials.gov lists a sponsor-submitted Phase 2a human study of investigational MOTS-c as recruiting. The record, NCT07505745, describes a randomized, placebo-controlled trial in 120 adults with prediabetes and overweight or obesity.
That is a meaningful step beyond cell and animal research. It is not evidence that MOTS-c is effective, safe, or FDA approved. No results are posted, the registry information is supplied by the sponsor, and ClinicalTrials.gov expressly warns that listing a study does not mean the U.S. government has reviewed or approved its safety or scientific validity.
What is MOTS-c?
MOTS-c—short for “mitochondrial open reading frame of the 12S rRNA type-c”—is a 16-amino-acid mitochondrial-derived peptide. Unlike most peptides discussed in biology, it is encoded within mitochondrial DNA rather than the nuclear genome.
Researchers have studied MOTS-c as a signaling molecule involved in cellular energy regulation and metabolic stress responses. Proposed mechanisms include effects involving AMP-activated protein kinase, commonly abbreviated AMPK. Much of the experimental evidence for administered MOTS-c, however, comes from cultured cells and animal models.
Human research has previously measured naturally occurring MOTS-c in blood or tissue and examined its response to exercise and metabolic conditions. Those observational or physiology studies are not the same as administering investigational MOTS-c to determine whether it safely produces a clinical effect.
What does the new ClinicalTrials.gov record say?
The record is titled “MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity,” with the acronym MOTS-MET. It describes the following design:
- ClinicalTrials.gov identifier: NCT07505745
- Phase: Phase 2a, listed in the registry as Phase 2
- Sponsor: Hudson Biotech
- Status: Recruiting, last verified by the sponsor in March 2026
- Planned enrollment: 120 participants
- Ages: 18 to 65 years
- Design: randomized, parallel-group, placebo-controlled and quadruple-masked
- Location currently listed: Peking University Shenzhen Hospital in Shenzhen, China
- Treatment period: 12 weeks
- Follow-up: through Week 16 for safety
- Route and schedule: subcutaneous injection, fixed dose once daily
- Actual study-start date reported by the sponsor: February 2, 2026
- Estimated primary completion: February 14, 2027
- Estimated study completion: May 17, 2028
The registry does not disclose the fixed dose in its public intervention description. It would therefore be inaccurate to infer or publish a trial dose from commercial protocols, forums, vendor pages, or unrelated animal studies.
What is the trial trying to find out?
The study has two listed primary outcomes.
The first is the change from baseline in insulin sensitivity after 12 weeks, calculated from a 75-gram oral glucose tolerance test using the Matsuda Index. The second is the incidence of treatment-emergent adverse events through 16 weeks.
Listed secondary outcomes include changes in:
- HbA1c;
- fasting glucose;
- two-hour glucose during the oral glucose tolerance test; and
- anti-drug antibodies, if applicable.
This design can address whether the investigational intervention produces a measurable signal under controlled conditions and can collect short-term safety information. It cannot, by itself, establish long-term safety, broad effectiveness, effects in other populations, or benefits unrelated to the prespecified outcomes.
Why the Phase 2 label needs context
“Phase 2” sounds definitive, but a phase label describes the intended development stage and study objectives. It is not a result.
ClinicalTrials.gov states that sponsors or investigators submit their own study information and remain responsible for its safety, science, and accuracy. National Library of Medicine staff perform a limited review for apparent errors, deficiencies, or inconsistencies; they do not independently validate the scientific merits of every listed study.
The MOTS-MET record also marks “FDA-regulated drug” as “No” and currently lists a study site in China. The listing should therefore not be described as an FDA-authorized Phase 2 trial, proof of an FDA-cleared Investigational New Drug application, or evidence that FDA has endorsed MOTS-c.
A precise description is: a sponsor-registered Phase 2a human trial of MOTS-c is listed as recruiting on ClinicalTrials.gov.
Does “recruiting” mean participants have received MOTS-c?
Not necessarily. “Recruiting” means the study is open to enrolling participants according to the sponsor’s latest registry update. The record reports an actual study start date, but it does not post enrollment totals, dosing confirmations, interim data, or results.
Until the sponsor reports those details through a registry update, conference presentation, regulatory disclosure, or peer-reviewed publication, we should not assume how many participants have enrolled or completed treatment.
Does the trial show that MOTS-c works in humans?
No. A trial registration is a plan to collect evidence, not the evidence produced by the trial.
As of this review, ClinicalTrials.gov shows no posted results for NCT07505745. It is therefore too early to claim that administered MOTS-c improves insulin sensitivity, lowers glucose, causes weight loss, enhances exercise performance, slows aging, or provides any other clinical benefit in humans.
The distinction is especially important because many widely repeated MOTS-c claims trace to mouse experiments. For example, published animal studies have investigated metabolic signaling, exercise capacity, muscle biology, and mitochondrial function. Human studies have also examined endogenous MOTS-c levels, but measuring a peptide already present in the body does not demonstrate that an injected investigational product is safe or therapeutic.
Is MOTS-c FDA approved?
No. A ClinicalTrials.gov listing is not FDA approval, and MOTS-c is not approved by FDA to diagnose, treat, cure, or prevent a medical condition.
FDA’s July 2026 Pharmacy Compounding Advisory Committee materials discussed MOTS-c-related bulk drug substances in connection with possible use in compounding. That advisory process is legally and scientifically separate from approval of a drug after adequate clinical testing. An advisory committee discussion or recommendation is not marketing approval and does not establish clinical efficacy.
How does this change the MOTS-c evidence picture?
The new registration matters because it proposes a randomized, masked comparison of administered MOTS-c against placebo in humans. If the study enrolls as planned, completes, and reports usable results, it could address an important gap between preclinical findings and clinical evidence.
But the evidence hierarchy has not yet changed at the outcome level. Today, the appropriate summary is:
- Cell and animal studies provide biological rationale and hypotheses.
- Human observational and exercise studies show that endogenous MOTS-c can be measured and may vary under certain conditions.
- A Phase 2a interventional human study is registered as recruiting.
- No results from that trial are posted.
- No clinical benefit or acceptable safety profile has been established by this registration.
What should researchers watch next?
The most informative updates will be:
- recruitment-status changes and additional study locations;
- protocol amendments or disclosure of the investigational dose;
- confirmation of actual enrollment and participant disposition;
- results for the Matsuda Index and safety outcomes;
- anti-drug-antibody findings;
- completeness of adverse-event reporting;
- whether results appear in a peer-reviewed publication; and
- whether the sponsor reports all prespecified outcomes, not only favorable findings.
Estimated completion dates can change. The registry should be checked again before describing the study’s status in future coverage.
Frequently asked questions
Is MOTS-c being tested in humans?
ClinicalTrials.gov lists NCT07505745 as a recruiting interventional study in adults. Earlier human research largely measured endogenous MOTS-c rather than testing administered MOTS-c as a treatment.
Is this a completed Phase 2 trial?
No. The study is listed as recruiting, with primary completion estimated for February 2027 and full completion estimated for May 2028. No results are posted.
Does Phase 2 mean MOTS-c passed Phase 1?
The public record labels this study Phase 2a but does not, by itself, document a completed Phase 1 program for the same investigational product. A phase label should not be used to infer undisclosed prior studies or regulatory determinations.
Is the trial being conducted in the United States?
The current record lists one recruiting site at Peking University Shenzhen Hospital in China. It does not currently list a U.S. site.
Can this registry record support a dose or protocol for personal use?
No. The public record does not disclose the fixed dose, and a clinical trial is conducted under controlled research oversight. It is not a personal-use protocol or medical recommendation.
The bottom line
MOTS-c has reached a notable milestone: a sponsor-registered Phase 2a placebo-controlled human trial is listed as recruiting. The scientifically responsible conclusion stops there.
The record confirms the study’s planned design and stated status. It does not supply results, validate online efficacy claims, establish long-term safety, or confer FDA approval. For now, the trial is a reason to watch the evidence—not a reason to treat an unanswered research question as a clinical conclusion.
For broader background, read the JD BioWorks MOTS-c research evidence review and review MOTS-c research materials and documentation for qualified laboratory use.
Sources
1. ClinicalTrials.gov. NCT07505745: MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity.
2. ClinicalTrials.gov. Disclaimer: responsibility for submitted study information.
3. Gudiksen A, et al. MOTS-c improves intrinsic muscle mitochondrial bioenergetic health and efficiency in a PGC-1α/AMPK-dependent manner. Free Radical Biology and Medicine. 2026.
4. Reynolds JC, et al. MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis. Nature Communications. 2021.
5. von Walden F, et al. Acute endurance exercise stimulates circulating levels of mitochondrial-derived peptides in humans. Journal of Applied Physiology (1985). 2021.
6. U.S. Food and Drug Administration. July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting materials.
Medical and research-use disclaimer: This article provides general educational information about a clinical-trial registration and the state of MOTS-c research. It does not provide individualized medical advice or recommend participation in a study. Discuss medical and clinical-trial decisions with a qualified health professional and the study team. JD BioWorks materials are intended for research use only and are not for human or veterinary use.
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