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New treatment option for Prediabetes
Official title MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity
ClinicalTrials.gov ID: NCT07505745
What this study is testing
What is MOTS-c (MDP)?
MOTS-c (MDP) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for prediabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 2a study evaluates whether 12 weeks of treatment with investigational MOTS-c improves insulin sensitivity compared with placebo in adults with prediabetes and overweight/obesity. Participants are randomized 1:1 to MOTS-c or placebo, receive standardized lifestyle counseling, and are followed for safety through Week 16.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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) \ 2.5x upper limit of normal at screening.
- Active malignancy requiring treatment (except adequately treated non-melanoma skin cancer).
See the full eligibility 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.
- 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) \ 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).
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.