MOTS-c injection for insulin sensitivity in adults with prediabetes
Tests MOTS-c, an experimental peptide, against placebo in adults with prediabetes.
Plain-language title generated from the registry record
Registry title: MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07505745, who can take part
Where in China
- Peking University Shenzhen HospitalShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hudson Biotech
- Trial code
- NCT07505745
- Record updated
- 1 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Known hypersensitivity to peptide therapeutics or any component of the investigational product formulation; 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; Active malignancy requiring treatment (except adequately treated non-melanoma skin cancer); 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); 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; 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; Pregnant, breastfeeding, or planning pregnancy during the study period.