Clinical trial

MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity

Recruiting now · Phase 2 · 1 countries · Registry ID NCT07505745

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionPrediabetes, Insulin Resistance, Overweight/Obesity

Full registry criteria

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).

Treatments and study arms

MOTS-c (MDP)

Drug

Drug: MOTS-c (MDP)

Placebo

Drug

Drug: Placebo

Route Subcutaneous injection

Other

injection

Regimen

Other

Fixed dose once daily for 12 weeks

Primary outcomes

Change from baseline in OGTT-derived insulin sensitivity (Matsuda Index)12 Weeks
Incidence of treatment-emergent adverse events (TEAEs)16 weeks

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Peking University Shenzhen Hospital🇨🇳 Shenzhen, Guangdong, China
Zhen J Peng, PhdContact