Could a mitochondrial peptide help reverse prediabetes?
NCT ID NCT07505745
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an investigational drug called MOTS-c in 120 adults with prediabetes and overweight or obesity. The goal is to see if 12 weeks of treatment can improve how the body uses insulin, compared to a placebo. All participants also receive standard lifestyle advice. The study is currently recruiting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 65 years at the time of consent. * Body mass index (BMI) 27.0 to 40.0 kg/m\^2. * Prediabetes documented at screening by any of the following: (a) HbA1c 5.7% to 6.4%; (b) fasting plasma glucose 100 to 125 mg/dL; or (c) 2-hour plasma glucose 140 to 199 mg/dL during a 75 g OGTT. * Stable body weight (less than 5% change) for at least 3 months prior to screening. * Willingness to maintain stable diet and physical activity patterns during the 12-week treatment period. * For participants of childbearing potential: agreement to use highly effective contraception for the study duration and for a protocol-specified period after last dose. * Ability to understand and sign informed consent. Exclusion Criteria: * Diabetes mellitus (e.g., HbA1c 6.5% or higher, fasting plasma glucose 126 mg/dL or higher, or 2-hour glucose 200 mg/dL or higher at screening). * Use of glucose-lowering medications (including metformin, GLP-1 receptor agonists, SGLT2 inhibitors) within 3 months prior to screening. * History of bariatric surgery or planned weight-loss surgery during the study period. * Clinically significant cardiovascular disease within 6 months (e.g., myocardial infarction, stroke, unstable angina) or uncontrolled hypertension. * Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2, clinically significant hepatic disease, or ALT/AST \> 2.5x upper limit of normal at screening. * Active malignancy requiring treatment (except adequately treated non-melanoma skin cancer). * Pregnant, breastfeeding, or planning pregnancy during the study period. * Known hypersensitivity to peptide therapeutics or any component of the investigational product formulation. * Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results (e.g., inability to comply with study procedures).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
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