Actively Recruiting
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of MOTS-c in Adults With Prediabetes and Overweight/Obesity
Led by Hudson Biotech · Updated on 2026-04-01
120
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years at the time of consent
- Body mass index (BMI) between 27.0 and 40.0 kg/m²
- Prediabetes confirmed by HbA1c 5.7% to 6.4%, fasting plasma glucose 100 to 125 mg/dL, or 2-hour plasma glucose 140 to 199 mg/dL during a 75 g oral glucose tolerance test
- Stable body weight with less than 5% change for at least 3 months before screening
- Willingness to maintain stable diet and physical activity during the 12-week treatment
- For participants who can become pregnant: agreement to use highly effective contraception during the study and for a specified period after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis of diabetes mellitus (HbA1c 6.5% or higher, fasting plasma glucose 126 mg/dL or higher, or 2-hour glucose 200 mg/dL or higher)
- Use of glucose-lowering medications within 3 months before screening
- History of or planned bariatric or weight-loss surgery during the study
- Significant cardiovascular disease within 6 months or uncontrolled high blood pressure
- Reduced kidney function (eGFR below 60 mL/min/1.73 m²), serious liver disease, or elevated liver enzymes above 2.5 times normal
- Active cancer needing treatment (except treated non-melanoma skin cancer)
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Known allergy to peptide drugs or study product components
- Any condition that could interfere with participation or study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive daily subcutaneous injections of MOTS-c or placebo and standardized lifestyle counseling to improve insulin sensitivity and cardiometabolic risk markers.
Weekly visits for up to 12 weeks
Duration - 4 weeks
Participants are monitored for safety after the treatment period ends.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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