ClinicalTrials.gg
RecruitingNCT07140809phase Ib/Ⅱa stUpdated Dec 30, 2025

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

A Phase 1/2 interventional study of JMT202 injection and Placebo in Hypertriglyceridemia, sponsored by Shanghai JMT-Bio Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Shanghai JMT-Bio Inc. (part of CSPC Pharmaceutical Group Limited) · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertriglyceridemia

Browse trials for

03

In context

Hypertriglyceridemia

324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.

This study's planned enrollment of 48 is below the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Shanghai JMT-Bio Inc. is the lead sponsor of 42 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 and ≤75 years old (at the time of signing the form), gender not limited.
  • The weight is ≥45.0 kg (for females) or ≥50.0 kg (for males), and the 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 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

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 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, , 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 surface antigen, virus antibody, Treponema pallidum antibody or 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 drugs, or who are determined by the researcher to be allergic to the drug;
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    JMT202

    Participants received JMT202 as an injection according to the protocol.

    Biological: JMT202 injection

  • Placebo comparator
    Placebo

    Participants received placebo as an injection according to the protocol.

    Other: Placebo

Interventions

  • BiologicalJMT202 injection

    Subcutaneous injection

  • OtherPlacebo

    Matching Placebo

06

What researchers measure

Primary outcomes

  1. The incidence and severity of TEAE

    Time frame: Day 1 to 99

  2. Number of participants with vital sign abnormalities

    Time frame: Day 1 to 99

  3. Number of participants with physical examination abnormalities

    Time frame: Day 1 to 99

  4. Number of participants with laboratory tests abnormalities

    Time frame: Day 1 to 99

  5. Number of participants with 12-lead electrocardiogram abnormalities

    Time frame: Day 1 to 99

  6. Number of participants with injection site reactions abnormalities

    Time frame: Day 1 to 63

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07140809
Responsible party
Sponsor
First posted
Aug 26, 2025
Start date
Sep 9, 2025
Primary completion
Jul 31, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Dec 30, 2025

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
86-0311-69085587

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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