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
• 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,
⁃ 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.