a Phase 1b/2a Study of JMT202 Injection in Participants With Hypertriglyceridemia
ConditionHypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai JMT-Bio Inc.
About this trial
To evaluate the safety and tolerability of multiple subcutaneous injections of JMT202 injection in Chinese participants with hypertriglyceridemia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Receive stable lipid-lowering treatment for ≥28 days before screening;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
JMT202 injection
Biological/VaccineSubcutaneous injection
Placebo
Other interventionMatching Placebo
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: JMT202Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence and severity of TEAE
Time frame
Day 1 to 992
Number of participants with vital sign abnormalities
Time frame
Day 1 to 993
Number of participants with physical examination abnormalities
Time frame
Day 1 to 994
Number of participants with laboratory tests abnormalities
Time frame
Day 1 to 99Sponsors and contacts
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Source ClinicalTrials.gov