HypertriglyceridemiaPhase 1/2phase Ib/Ⅱa stNCT07140809
a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia
A Phase 1/2 study testing JMT202 injection in people with Hypertriglyceridemia, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- JMT202 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2025to 1 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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:
- 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 lipid-lowering within 28 days before,
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- 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 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Peking University
Beijing, Beijing Municipality
About this study
Official title: 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
To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia
- Conditions
- Hypertriglyceridemia
- Being tested
- JMT202 injection, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT202 injectionBiological
Subcutaneous injection
PlaceboOther
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| JMT202 | Experimental | Participants received JMT202 as an injection according to the protocol. Receives: Biological: JMT202 injection |
| Placebo | Placebo comparator | Participants received placebo as an injection according to the protocol. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of TEAE
Measured: Day 1 to 99
Number of participants with vital sign abnormalities
Measured: Day 1 to 99
Number of participants with physical examination abnormalities
Measured: Day 1 to 99
Number of participants with laboratory tests abnormalities
Measured: Day 1 to 99
Number of participants with 12-lead electrocardiogram abnormalities
Measured: Day 1 to 99
Number of participants with injection site reactions abnormalities
Measured: Day 1 to 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start9 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140809
- Sponsor's protocol ID
- JMT202-002
- Acronym
- phase Ib/Ⅱa st
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07140809
- Acronym / sponsor ID
- phase Ib/Ⅱa st / JMT202-002
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JMT202 | Experimental | Biological: JMT202 injectionParticipants received JMT202 as an injection according to the protocol. |
| Placebo | Placebo comparator | Other: PlaceboParticipants received placebo as an injection according to the protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Some participants (at least 4 cases per dose group) had MRI-PDFF≥8%;
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMT202 injectionSubcutaneous injection | Biological | JMT202 |
| PlaceboMatching Placebo | Other | Placebo |
Primary outcome
The incidence and severity of TEAE
Time frame: Day 1 to 99
Number of participants with vital sign abnormalities
Time frame: Day 1 to 99
Number of participants with physical examination abnormalities
Time frame: Day 1 to 99
Number of participants with laboratory tests abnormalities
Time frame: Day 1 to 99
Number of participants with 12-lead electrocardiogram abnormalities
Time frame: Day 1 to 99
Number of participants with injection site reactions abnormalities
Time frame: Day 1 to 63
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JMT202 injection in people with Hypertriglyceridemia, run by Shanghai JMT-Bio Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of TEAE (time frame: Day 1 to 99). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.