Actively Recruiting
MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity
Led by Hudson Biotech · Updated on 2026-04-01
120
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official 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) 27.0 to 40.0 kg/m^2.
- 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 OGTT.
- Stable body weight with less than 5% change for at least 3 months before screening.
- Willing to maintain stable diet and physical activity during the 12-week treatment.
- Agreement to use highly effective contraception for participants of childbearing potential during and after the study.
- 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 surgery during the study period.
- Significant cardiovascular disease within 6 months or uncontrolled hypertension.
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m^2, significant liver disease, or elevated liver enzymes over 2.5 times the upper normal limit.
- Active cancer requiring treatment, except treated non-melanoma skin cancer.
- Pregnancy, breastfeeding, or planning pregnancy during the study.
- Known allergy to peptide drugs or any study drug components.
- Any condition that might 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
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
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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