MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity
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
Hudson Biotech
120 participants
Feb 2, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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 Criteria9
- 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).
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Interventions
Drug: MOTS-c (MDP)
Drug: Placebo
injection
Fixed dose once daily for 12 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07505745