Actively Recruiting
a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia
Led by Shanghai JMT-Bio Inc. · Updated on 2025-12-30
48
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia
CONDITIONS
Official Title
a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at informed consent
- Weight ≥45.0 kg (female) or ≥50.0 kg (male) with BMI between 24.0 and 40.0 kg/m²
- Triglycerides >300 mg/dL within 28 days before screening
- Two triglyceride tests during screening at least 7 days apart, both between 300 mg/dL and 1000 mg/dL
- Last triglyceride test less than 7 days before first dose
- Stable lipid-lowering treatment for at least 28 days before screening or meeting specific triglyceride treatment criteria
- At least 4 participants per dose group with MRI-PDFF ≥8%
- Maintain original diet, exercise, and lifestyle habits from 28 days before screening through study
- Avoid alcohol and strenuous exercise within 48 hours before each visit
- Agree to use effective contraception from consent until 6 months after study end
- Ability to communicate with researchers and comply with trial requirements
You will not qualify if you...
- Weight change >5% within 3 months before randomization or planned weight loss during trial
- Use of FGF21-targeting products within previous year
- Type 1 diabetes without stable hypoglycemic treatment in past 3 months or prohibited medications use
- Known or suspected familial hyperchylomicemia or related lipid disorders
- History of gallbladder disease with symptoms unless removed ≥6 months ago
- Acute or chronic pancreatitis within 12 months before screening
- Atherosclerotic cardiovascular disease or major cardiovascular/cerebrovascular events within 6 months before screening
- History of malignant tumors within 5 years except certain skin or cervical cancers
- Severe infections within 3 months before screening deemed unsuitable
- Poor blood pressure control during screening or unstable antihypertensive therapy
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Use of other lipid regulators (excluding specified lipid-lowering drugs) within 28 days before screening
- Dermatitis or abnormal skin at injection site
- History of severe allergies or use of immunosuppressants or allergy to study drug
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Peking University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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