Phase 2a Study of MOTS-c Injection to Improve Insulin Sensitivity in Adults with Prediabetes and Overweight or Obesity

What this Trial Is About

Researchers are evaluating whether 12 weeks of treatment with the investigational drug MOTS-c can improve insulin sensitivity in adults with prediabetes who are also overweight or obese. This Phase 2a, randomized, double-blind, placebo-controlled study aims to understand if MOTS-c affects insulin sensitivity and cardiometabolic risk markers. The study is based on preclinical findings that suggest MOTS-c influences metabolic processes through skeletal muscle and AMPK activation. Participants are randomly assigned to receive either MOTS-c or a matching placebo, both combined with standardized lifestyle counseling. The treatment is given as a fixed dose once daily by subcutaneous injection for 12 weeks. The study includes a screening period of up to 4 weeks, a 12-week treatment period, and a 4-week post-treatment safety follow-up. Throughout the study, participants undergo assessments such as a 75 g oral glucose tolerance test to measure insulin sensitivity, along with evaluations of HbA1c, fasting glucose, lipids, body weight, and waist circumference. Safety is monitored through adverse event tracking, vital signs, ECG, and laboratory tests. The study follows participants for a total of 16 weeks to evaluate changes and monitor potential treatment-related effects.

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