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
Qualifiers
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
Treatments tested in this trial
- JMT202 injection
- Placebo
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov