Actively Recruiting
A Multiple-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Escalation Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JMT202 Injection in Chinese Participants With Hypertriglyceridemia
Led by Shanghai JMT-Bio Inc. · Updated on 2025-12-30
48
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of multiple subcutaneous injections of JMT202 in Chinese adults with hypertriglyceridemia. This study is a Phase 1b/2a randomized, double-blind, placebo-controlled trial aimed at assessing how participants respond to this investigational treatment, including its effects on triglyceride levels and overall health markers. Participants will receive either JMT202 injections or placebo injections according to the study protocol. The study involves multiple doses administered under medical supervision. Some participants in each dose group will also undergo MRI-PDFF scans to assess fat content. Throughout the trial, participants are expected to maintain their usual diet and exercise habits while avoiding alcohol and strenuous exercise before visits. During the study, participants will undergo regular safety assessments including monitoring for treatment-emergent adverse events, vital signs, physical exams, laboratory tests, electrocardiograms, and injection site reactions from Day 1 to Day 99. The trial period includes careful observation of health changes and adherence to stable lipid-lowering treatments. The total duration of participant involvement spans from screening through approximately three months of follow-up after treatment begins.
CONDITIONS
Brief 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 old at the time of signing the informed consent
- Weight of at least 45.0 kg for females or 50.0 kg for males
- Body mass index (BMI) between 24.0 and 40.0 kg/m²
- Triglyceride levels above 300 mg/dL within 28 days before screening with two values at least 7 days apart meeting 300 mg/dL ≤ TG < 1000 mg/dL
- Stable lipid-lowering treatment for at least 28 days before screening or specific lipid-lowering status as outlined in criteria
- At least 4 participants per dose group with MRI-PDFF ≥ 8%
- Maintain original diet, exercise, and lifestyle habits throughout the trial
- Use effective contraception from consent signing until 6 months after trial ends
- Ability to communicate normally and comply with trial requirements
You will not qualify if you...
- Weight change of 5% or more within 3 months before randomization or planned weight loss during the trial
- Use of FGF21-targeting products within the past year
- Unstable Type 1 diabetes treatment or prohibited hypoglycemic drugs usage
- Known or suspected familial hyperchylomicemia or related lipid disorders
- History of gallbladder disease with symptoms or recent acute or chronic pancreatitis
- History of major cardiovascular or cerebrovascular diseases within 6 months prior to screening
- History of malignant tumors within the past 5 years except certain skin and cervical cancers
- Severe infections within 3 months before screening
- Poor blood pressure control or unstable antihypertensive treatment
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Use of certain lipid regulators or supplements outside allowed treatments during the trial
- Dermatitis or abnormal skin at the injection site
- History of severe drug or food allergies or use of immunosuppressants
- Allergic reaction to the investigational drug as determined by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 99 days
Participants receive multiple doses of JMT202 injection or placebo as part of the study to evaluate safety, tolerability, efficacy, and pharmacokinetics.
Multiple visits during treatment period
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
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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