MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHudson Biotech
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 to 65 years at the time of consent.
Body mass index (BMI) 27.0 to 40.0 kg/m².
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MOTS-c (MDP)
- Placebo
- Route Subcutaneous injection
- Regimen
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov