MOTS-c to improve insulin sensitivity in adults with prediabetes and overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MOTS-c is a mitochondrial-derived peptide thought to regulate insulin sensitivity, with preclinical work suggesting effects on skeletal muscle and activation of AMPK. In this randomized, double-blind Phase 2a study, adults with prediabetes and BMI 27–40 kg/m2 are assigned 1:1 to subcutaneous MOTS-c or placebo and receive standardized lifestyle counseling. Efficacy is measured primarily by an OGTT-derived insulin sensitivity index and secondarily by HbA1c, fasting glucose, lipids, body weight, and waist circumference. Safety is monitored through adverse events, vital signs, ECG, labs, and a 4-week post-treatment follow-up.

Why it matters

Who can join: the full rules

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).

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Avocado Diet Study for Prediabetes and Insulin Resistance

  This study tests whether eating an avocado-rich meal plan for four weeks can improve triglyceride and glucose metabolism in adults with prediabetes and insulin resistance.

  Recruiting Clinical Nutrition Research Center, Illinois Institute of Technology · Chicago, Illinois · NCT07624500

• Cranberry for gut and metabolic health in adults with overweight or obesity

  This study will test whether drinking a cranberry beverage can improve blood sugar control, insulin sensitivity, blood lipids, and gut microbiota in adults with overweight or obesity who have metabolic risk factors.

  Recruiting Laval University · Québec, Quebec · NCT07460856

• Digital health coaching using wearable technology for chronic disease prevention

  This study is testing whether digital health coaching with wearable technology can help people at risk of chronic diseases like high blood pressure and diabetes make healthier lifestyle choices to prevent these conditions.

  Recruiting Alexandra Hospital · Singapore · NCT06752772

• Understanding how metabolism and inflammation affect diabetes in teens

  This study is trying to see how body weight, lifestyle, and diet affect inflammation and metabolism in teens to better understand diabetes risk.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT06007404

• Understanding how obesity affects insulin resistance through diet and molecular profiling

  This study is trying to see how different diets can affect insulin resistance in people with obesity by looking at changes in their body and blood over 12 weeks.

  Recruiting Stanford University · Stanford, California · NCT05165706

• Asprosin and miRNA Profiles in Young Women with Metabolic Syndrome

  This study tests whether certain blood biomarkers, including asprosin and six microRNAs, differ between young women with metabolic syndrome and healthy peers.

  Recruiting University of Applied Sciences in Nowy Targ · Nowy Targ, Lesser Poland Voivodeship · NCT07917364

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.