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New treatment option for Hypertriglyceridemia
Official title a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia
ClinicalTrials.gov ID: NCT07140809
What this study is testing
What is JMT202 injection?
JMT202 injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypertriglyceridemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age ≥18 and ≤75 years old (at the time of signing the informed consent form), gender not limited.
- The weight is ≥45.0 kg (for females) or ≥50.0 kg (for males), and the body mass index is between 24.0 and 40.0 kg/m ² (including the cut-off value)...
- TG\>300 mg/dL (3.39 mmol/L) within 28 days before screening; During the screening period, the TG of the participants met the following requirements...
- Participants need to meet:
- Receive stable lipid-lowering treatment for ≥28 days before screening;
You likely can't join if
- Weight changed by ≥5% within the 3 months prior to randomization, or who planned to lose weight throughout the trial period;
- Screening products targeting the FGF21 target that have been used within the previous year, such as BIO89-100, DR10624, etc.
- Participants with Type 1 diabetes No stable hypoglycemic drug treatment within 3 months prior to screening or randomization (the use of glucagon-like...
- Participants who are known or suspected of having familial hyperchylomicemia, lipoprotein lipase injury or deficiency (Fredrickson type 1)...
- Participants with a history of gallbladder disease and have symptoms before Screen or randomly (such as common bile duct stones, multiple gallbladder...
- Participants had a history of acute pancreatitis attacks or chronic pancreatitis within 12 months prior to screening or randomization;
See the full eligibility criteria
Who can join
- Age ≥18 and ≤75 years old (at the time of signing the informed consent form), gender not limited.
- The weight is ≥45.0 kg (for females) or ≥50.0 kg (for males), and the body mass index is between 24.0 and 40.0 kg/m ² (including the cut-off value). The body mass index is calculated as [BMI= weight (kg)/height 2 (m ²)].
- TG\>300 mg/dL (3.39 mmol/L) within 28 days before screening; During the screening period, the TG of the participants met the following requirements: ① Two TG values within the screening period, with an interval of ≥7...
- Participants need to meet:
- Receive stable lipid-lowering treatment for ≥28 days before screening;
- Accept lipid-lowering medications before screening of less than 28 days, but random stable lipid-lowering therapy, 28 days or more before test TG and D - 1 \> 300 mg/dL (the tendency for 3.39 L) screening of unused...
- During the screening period, at least one screening should be conducted at a concentration of 300 mg/dL (3.39 mmol/L) ≤TG\<500 mg/dL (5.65 mmol/L).
- Screening unused lipid-lowering, within 28 days before screening period two TG 500 mg/dL or higher tendency (5.65 L), need before random stable lipid-lowering therapy, 28 days or TG test and D - 1 \> 300 mg/dL (the...
- Some participants (at least 4 cases per dose group) had MRI-PDFF≥8%;
- From 28 days before screening to the entire trial period, participants should maintain their original diet, exercise and lifestyle habits as much as possible, and avoid alcohol and strenuous exercise within 48 hours...
- Participants and their partners agree that they must use effective and reliable contraceptive methods from the signing of the informed consent form until 6 months after the end of the trial (female participants are not...
- Participants voluntarily join the clinical trial and sign the informed consent form, and have the ability to communicate normally with the researchers while abiding by the trial requirements.
What rules you out
- Weight changed by ≥5% within the 3 months prior to randomization, or who planned to lose weight throughout the trial period;
- Screening products targeting the FGF21 target that have been used within the previous year, such as BIO89-100, DR10624, etc.
- Participants with Type 1 diabetes No stable hypoglycemic drug treatment within 3 months prior to screening or randomization (the use of glucagon-like peptide-1 receptor agonists, single-target or multi-target drugs...
- Participants who are known or suspected of having familial hyperchylomicemia, lipoprotein lipase injury or deficiency (Fredrickson type 1), apolipoprotein C-II deficiency or familial lipoprotein dyslipidemia...
- Participants with a history of gallbladder disease and have symptoms before Screen or randomly (such as common bile duct stones, multiple gallbladder stones, etc., unless the gallbladder has been removed and the removal...
- Participants had a history of acute pancreatitis attacks or chronic pancreatitis within 12 months prior to screening or randomization;
- people with atherosclerotic cardiovascular diseases in the 6 months prior to screening or randomization, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy...
- There were major cardiovascular and cerebrovascular diseases in the 6 months prior to screening or randomization;
- Having a history of malignant tumors in the past five years (excluding cured basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin or carcinoma in situ of cervical cancer), or potential...
- Participants have experienced severe infections within the three months prior to screening, including but not limited to: severe pneumonia, lung abscess, meningitis, cellulitis, etc., and are judged by the researchers...
- Participants with poor blood pressure control during the screening period (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg); Or the antihypertensive drugs of the participants have not been...
- Participants test positive for any one of hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antibody;
- Other lipid regulators (excluding lipid-lowering drugs in inclusion criterion 4) were used from 28 days before screening/randomization to the entire trial period (≥3 days), including niacin (\<375 mg/ day)...
- In the opinion of the investigator, the participants have symptoms such as dermatitis or abnormal skin around the abdominal administration site;
- Participants with a history of severe drug or food allergies, who have used immunosuppressant drugs, or who are determined by the researcher to be allergic to the investigational drug;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.