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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia

a Multiple-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Escalation Phase Ib/Ⅱa Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetic Characteristics of JMT202 Injection in Chinese Participants With Hypertriglyceridemia

a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia (NCT07140809) is a Phase 1 / Phase 2 interventional studying Hypertriglyceridemia, sponsored by Shanghai JMT-Bio Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Hypertriglyceridemia, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 and ≤75 years old (at the time of signing the willing to sign a consent form 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 days, and both TG values met the requirement of 300 mg/dL≤TG\<1000 mg/dL (11.30 mmol/L); ② The last TG test was less than 7 days before administration (D1). - Participants need to meet: 1. Receive stable lipid-lowering treatment for ≥28 days before screening; 2. 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 lipid-lowering within 28 days before, 3. 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). 4. 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 tendency for 3.39 L).Lipid-lowering treatment: niacin ≥375 mg/ day, prescription fish oil, fibrates, statins, ezetimibe, etc. PCSK9 inhibitors need to be stable for 6 months before screening. - 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 before each visit. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 days, and both TG values met the requirement of 300 mg/dL≤TG\<1000 mg/dL (11.30 mmol/L); ② The last TG test was less than 7 days before administration (D1). * Participants need to meet: 1. Receive stable lipid-lowering treatment for ≥28 days before screening; 2. 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 lipid-lowering within 28 days before, 3. 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). 4. 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 tendency for 3.39 L).Lipid-lowering treatment: niacin ≥375 mg/ day, prescription fish oil, fibrates, statins, ezetimibe, etc. PCSK9 inhibitors need to be stable for 6 months before screening. * 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 before each visit. * 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 allowed to use hormonal contraceptives from 14 days before screening until the entire trial period) to prevent pregnancy in either female or male participants' partners. Male participants had no sperm donation plans from signing the informed consent form to 6 months after the end of the trial, and female participants had no egg donation plans from signing the informed consent form to 6 months after the end of the trial. * 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. Exclusion Criteria: * 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, thiazolidinediones or insulin was prohibited from 3 months prior to screening until the entire trial period) Other oral or injectable drugs should have been stably treated for ≥3 months before screening and the dose should be maintained stably throughout the trial period, or the glycated hemoglobin should be ≥9.5% during the screening period. * 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 (Fredrickson type 3); * 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 time is ≥6 months); * Participants had a history of acute pancreatitis attacks or chronic pancreatitis within 12 months prior to screening or randomization; * Subjects 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, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease, etc., or those diagnosed with a high risk of atherosclerotic cardiovascular disease; * 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 malignant tumors currently under assessment; * 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 as unsuitable to participate in this trial; * 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 stable for ≥3 months before screening or randomization (thiazide diuretics and beta-blockers are prohibited from 3 months before screening to the entire trial period). * 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), over-the-counter or non-pharmaceutical strength fish oil, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterols/sterol products, polyphenols, etc. * 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;

Treatments Being Tested

BIOLOGICAL

JMT202 injection

Subcutaneous injection

OTHER

Placebo

Matching Placebo

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Hospital of Peking University
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07140809), the sponsor (Shanghai JMT-Bio Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07140809 clinical trial studying?

To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07140809?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07140809?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07140809. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07140809. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.